Merz Aesthetics Portfolio: Xeomin, Radiesse, Belotero, and Ultherapy FDA Tracking

What does the public regulatory data reveal about Merz Aesthetics and its core portfolio, and what should a clinic operator, medical director, regulatory affairs team, or provider do with it?

Analysis of the FDA medical device and drug databases shows that Merz Aesthetics maintains a highly diversified regulatory footprint. This dossier aggregates and analyzes 378 Premarket Approvals (PMAs)—including 315 Radiesse trade names and 61 Belotero configurations—alongside Xeomin's Biologics License Application (BLA) and more than 2,000 adverse event reports in the FDA's Manufacturer and User Facility Device Experience (MAUDE) database.

For clinical operators and market-access teams, this data highlights a series of significant 2025/2026 regulatory milestones, including the April 2026 FDA approval of Radiesse for décolleté wrinkles and the November 2025 FDA clearance of Ultherapy PRIME for arms and abdomen skin laxity.

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1. Corporate History and Strategic Acquisitions

Merz Aesthetics, a division of the Frankfurt-based Merz Group founded in 1908, has built its market presence through strategic acquisitions. This corporate evolution transitioned Merz from a traditional German pharmaceutical house into a global medical aesthetics leader:

• 2010 (BioForm Medical Acquisition): Merz acquired BioForm Medical for approximately $229 million. This transaction brought Radiesse (calcium hydroxylapatite) into the Merz fold, establishing the company’s injection footprint in the United States.
• 2013 (Anteis Acquisition): Merz acquired Swiss filler manufacturer Anteis, securing the patented Cohesive Polydensified Matrix (CPM) technology that powers the Belotero filler line.
• 2014 (Ulthera Acquisition): Merz acquired Ulthera, Inc. for approximately $600 million. This acquisition added microfocused ultrasound (MFU-V) to the portfolio, giving Merz a leading position in non-invasive skin tightening.

These corporate milestones consolidated a diverse regulatory landscape, bringing multiple PMAs and 510(k) clearances under Merz's compliance framework.

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2. Regulatory Pathways: PMA and 510(k) Distribution

Merz Aesthetics balances chemical injectables (neuromodulators and fillers) with energy-based tissue-tightening devices. Its regulatory strategies span the Center for Drug Evaluation and Research (CDER) for biological drugs and the Center for Devices and Radiological Health (CDRH) for Class II and Class III medical devices.

Premarket Approval (PMA) and 510(k) Distribution

A search of the FDA Medical Device PMA Database reveals that Merz Aesthetics and its subsidiaries hold a total of 378 PMA approvals and supplements (dominated by Radiesse and Belotero dermal implants under product code LMH), alongside 14 FDA 510(k) clearances for the Ulthera ultrasound system.

1. Radiesse (Product Code: LMH): Under the PMA number P050052, Merz holds 315 trade names representing various syringe volumes, calcium hydroxylapatite (CaHA) concentrations, and lidocaine-mixed configurations.
2. Belotero (Product Code: LMH): Under the PMA number P090016, Merz holds 61 trade names representing its cohesive polydensified matrix (CPM) hyaluronic acid formulations.
3. Ultherapy / Cellfina (Product Codes: OHV / OUP): Under product code OHV (focused ultrasound stimulator for aesthetic use), the Ulthera subsidiary holds 14 clearances — 10 under OHV for the Ultherapy and Ultherapy PRIME microfocused ultrasound with visualization (MFU-V) platforms, and 4 under OUP for the Cellfina cellulite subcision system.

Granular Regulatory Parameters of Merz Portfolio

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3. Xeomin: The Purified Protein Neuromodulator

Xeomin (incobotulinumtoxinA) is regulated as a biological drug under BLA 125360. In early 2026, Merz celebrated the 15th anniversary of Xeomin's U.S. aesthetic approval.

BLA Approval History

• July 30, 2010: The FDA grants initial BLA approval to Xeomin for therapeutic indications, specifically cervical dystonia and blepharospasm.
• July 20, 2011: The FDA approves Xeomin for the cosmetic indication of temporary improvement in the appearance of moderate to severe glabellar lines (frown lines) in adults.
• 2020: The FDA approves Xeomin for the temporary improvement of glabellar lines in adult patients, utilizing a dynamic dosing range.

The Purified Profile Claim

Xeomin's primary market differentiator is its manufacturing process. Through chromatography and filtration, Merz removes the complexing (accessory) proteins that surround the active 150 kDa botulinum toxin type A molecule.

• Accessory Proteins: Competitor neuromodulators like Botox and Dysport contain accessory proteins (hemagglutinins and non-toxic non-hemagglutinins) that form a larger molecular structure.
• Neutralizing Antibodies: In clinical studies, the presence of accessory proteins has been linked to the formation of neutralizing antibodies, which can cause "treatment resistance" or loss of efficacy over time. Xeomin's purified profile aims to reduce this immunogenic risk, making it a preferred option for long-term aesthetic patients.

Xeomin Reconstitution, Dosing, and Commercial Parameters

• Reconstitution Ratio: Xeomin is supplied as a lyophilized powder (50, 100, or 200 units per vial). It is reconstituted using preservative-free 0.9% sterile saline. The standard cosmetic concentration is 4 units per 0.1 mL (using 2.5 mL saline per 100-unit vial).
• Storage Stability: Un-reconstituted Xeomin can be stored at room temperature (up to 25°C) for up to 36 months.
• Dosing Equivalence: Clinical studies have demonstrated a 1:1 dosing equivalence between Xeomin and Botox. However, Xeomin cannot be converted to Dysport on a 1:1 basis, as Dysport units are calculated differently (typically requiring a 2.5:1 or 3:1 Dysport-to-Xeomin conversion ratio).

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4. Off-Label Clinical Dosing and Protocols for Xeomin

While Xeomin is FDA-approved cosmetic-wise for glabellar lines, experienced injectors frequently use it off-label to treat other areas of the face and neck. These protocols require precise dosing and anatomical positioning to prevent complications like ptosis or asymmetrical smiles:

Masseter Hypertrophy (Jaw Slimming & TMJ)

• Target Muscle: Masseter muscle.
• Dosing Range: 20–30 units per side (40–60 units total).
• Injection Technique: Injected deep into the muscle belly using a 27G 0.5-inch needle, targeting three points in a triangle within the safe zone (bounded by the tragus-oral commissure line, the anterior border of the masseter, and the lower border of the mandible).
• Clinical Goal: Atrophy of the masseter muscle over 4–6 weeks, reducing jaw width and relieving teeth-grinding symptoms.

Platysmal Bands (Nefertiti Lift & Neck Bands)

• Target Muscle: Platysma muscle bands.
• Dosing Range: 2–5 units per injection site, with 10–20 units per active vertical band (up to 40 units total).
• Injection Technique: The vertical band is pinched between the injector's fingers, and Xeomin is injected intramuscularly in a superficial grid along the band.
• Clinical Goal: Relaxation of the platysmal bands to smooth neck lines and reduce the downward pull on the jawline.

Micro-Botox / Intradermal Xeomin (Skin Quality)

• Target Depth: Intradermal (papillary dermis).
• Dosing Range: 10–20 units of Xeomin highly diluted in 1.0–2.0 mL of saline.
• Injection Technique: Microdroplets of 0.01–0.02 mL injected superficially, forming tiny blebs on the skin surface.
• Clinical Goal: Reduction of sebum production, decrease in pore size, and smoothing of fine crinkles without freezing underlying facial expression muscles.

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5. Neuromodulator Comparison: Xeomin vs. Competitors

To contextualize Xeomin’s regulatory and clinical position, the table below compares the key FDA-approved botulinum toxin type A products available in the U.S. market. For a deeper look at the purified-toxin option from the patient side, see our Xeomin patient guide; for a head-to-head of Botox against newer entrants including Xeomin and Letybo, see our Botox vs Letybo, Dysport, and Xeomin comparison.

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6. Radiesse: PMA Milestones and the April 2026 Décolleté Approval

Radiesse is a sterile, non-pyrogenic injectable implant consisting of synthetic calcium hydroxylapatite (CaHA) microspheres (30% by volume) suspended in a sodium carboxymethylcellulose gel carrier (70% by volume).

Evolution of Radiesse Indications (P050052)

1. December 22, 2006: Initial FDA approval for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds, and for the restoration of facial fat loss (lipoatrophy) in patients with HIV.
2. June 4, 2015 (P050052/S049): The FDA approves Radiesse for hand augmentation to correct volume loss in the dorsum of the hands (Product Code: PKY). This made Radiesse the first filler approved for hand rejuvenation.
3. April 2026 (P050052/S162): The FDA approved Radiesse for the treatment of moderate to severe wrinkles in the décolleté (chest) area for patients 22 years of age and older (approval order issued March 31, 2026; announced April 8, 2026). This marked the fourth FDA-approved indication for the product and made Radiesse the first biostimulator cleared in the U.S. for both face and body.

Histological Timeline: How CaHA Stimulates Collagen

Histological studies and biopsy reports trace the cellular response to injected CaHA over an extended timeline:

• Day 1 to 14: Immediate volume correction is provided by the carboxymethylcellulose (CMC) gel carrier, which occupies space and lifts the tissue.
• Week 4 to 8: The CMC carrier gel begins to biodegrade, and macrophages gradually phagocytize the gel. Fibroblasts migrate to surround the CaHA microspheres.
• Month 3: The CaHA microspheres stimulate fibroblasts to synthesize new collagen fibers (principally Type III collagen initially, which is later replaced by stronger Type I collagen). Fibroblast activation peaks at this stage.
• Month 12 to 18: The CaHA microspheres are slowly broken down by the body's natural metabolic processes into calcium and phosphate ions, which are excreted. The newly formed collagen network remains, providing long-lasting tissue thickness and support.

Clinical Protocol: Hyperdilution and Syringe Preparation

To ensure uniform particle distribution and prevent clogging during injection, clinicians must follow a strict mixing protocol:

        RADIESSE HYPERDILUTION MIXING SYSTEM
  ┌──────────────────────────────────────────────────┐
  │ 1. Connect Radiesse Syringe to Luer-Lock Connector│
  │ 2. Connect Diluent Syringe (Saline + Lidocaine)  │
  │ 3. Perform 20 Passages (Trituration) to Blend   │
  │                                                  │
  │ Ratios:                                          │
  │  [ ] 1:1 (Neck Laxity)                           │
  │      1.5 mL Radiesse + 1.5 mL Diluent            │
  │  [ ] 1:2 (Décolleté Wrinkles)                    │
  │      1.5 mL Radiesse + 3.0 mL Diluent            │
  │  [ ] 1:3 (Upper Arms / Abdomen)                  │
  │      1.5 mL Radiesse + 4.5 mL Diluent            │
  └──────────────────────────────────────────────────┘

The injection is performed in the subdermal plane (just below the dermis and above the subcutaneous fat) using a 25G or 27G 1.5-inch cannula to ensure even placement and minimize bruising. A fanning or retrograde linear threading technique is used, delivering approximately 0.05 mL of diluted product per thread. Immediate post-treatment massage is mandatory to distribute the CaHA microspheres and prevent the formation of localized nodules.

Clinical Decision Tree for Radiesse Dilution Ratios

To tailor Radiesse to varying skin thicknesses and anatomical regions, clinical operators utilize a standardized dilution matrix based on the patient's laxity score and skin thickness:

Clinical Protocol for Radiesse Vascular Occlusion Management

Because calcium hydroxylapatite is a particulate filler, its accidental intravascular injection is highly problematic because it cannot be dissolved by hyaluronidase. Clinical teams must maintain an emergency kit and follow an immediate, aggressive intervention protocol:

1. Immediate Cessation: Stop the injection immediately upon the first sign of blanching, dusky discoloration, livedo reticularis, or sudden, localized pain. Do not withdraw the needle/cannula until the syringe is disconnected to avoid pulling product into secondary vessels.
2. Mechanical Dispersion: Apply intense, vigorous massage to the affected area to mechanically disperse the CaHA microspheres, breaking up the intra-arterial bolus and allowing collateral blood flow.
3. Thermal Vasodilation: Apply continuous warm compresses to the area to induce local vasodilation.
4. Pharmacological Vasodilation: Apply topical 2% nitroglycerin ointment under an occlusive dressing for 12 hours, monitoring the patient for systemic hypotension or severe headache.
5. Hyperbaric Oxygen (HBOT) Therapy: If capillary refill remains delayed (>2 seconds) after 2 hours of local treatment, immediately transfer the patient to a hyperbaric oxygen facility to support cellular viability during transient tissue ischemia.
6. Adjunctive Therapies: Administer low-dose aspirin (325 mg orally) to prevent platelet aggregation on the CaHA particles, and administer local subcutaneous injections of saline or lidocaine to mechanically dilute the localized particulate concentration.

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7. Belotero: CPM HA Filler and October 2025 Submissions

Belotero Balance is a hyaluronic acid dermal filler manufactured using a patented Cohesive Polydensified Matrix (CPM) process. This process yields a gel with varying zones of high and low density, allowing the filler to integrate smoothly into the superficial dermis without causing the Tyndall effect.

CPM Technology and Rheology Comparisons

The CPM technology utilizes a double-cross-linking process. Hyaluronic acid is first cross-linked with BDDE, then un-cross-linked HA is added and cross-linked again. This yields a single gel containing sections of varying densities.

• Elastic Modulus (G'): Belotero Balance has a relatively low G' (approximately 80 Pa) and low viscosity compared to Restylane (G' approx. 600 Pa) or Juvéderm Voluma (G' approx. 300 Pa). This allows it to flow easily under light extrusion force and adapt to delicate tissue spaces.
• Cohesivity: Belotero displays high cohesivity, meaning the gel particles stay together under stress. This prevents the gel from separating into discrete lumps under facial movement.
• Tyndall Effect Prevention: The cohesive polydensified structure integrates between dermal collagen bundles rather than pushing them aside, preventing the light scattering that creates a blue tint under the skin.

Belotero's CPM technology was originally developed by Anteis in Switzerland. By using a double-crosslinking method, it allows the HA molecules to form a monophasic polydensified gel, which exhibits high elasticity and low viscosity, enabling smooth injection through very thin needles (e.g. 30G or 32G). This rheology provides a distinct clinical advantage over traditional biphasic gels that contain particulate HA suspended in an un-crosslinked carrier, which are prone to superficial lumpiness and blue-light scattering. In terms of clinical practice, this allows practitioners to achieve a seamless blend at the dermal interface, rendering it highly effective for vertical lip lines, superficial crow's feet, and delicate forehead wrinkles.

2025 PMA Submissions and the Volume (+) Lidocaine Approval

• PMA Submissions (July 2025): On July 30, 2025, Merz announced FDA Premarket Approval Applications for Belotero Volume Lidocaine and Belotero Intense Lidocaine, extending the CPM range with lidocaine-containing formulations for midface volume and deep folds.
• Belotero Volume (+) Lidocaine (P250020): This formulation subsequently received FDA approval (P250020) for midface volume restoration and cheek fullness. Its pivotal trial used the validated Merz Cheek Fullness Assessment Scale (MCFAS): 96% of participants maintained at least a 1-point improvement in both cheeks at 12 weeks (live assessment), with the majority maintaining improvement through 48 weeks.

Belotero Portfolio Comparison and Rheology Matrix

The Belotero family of CPM fillers is engineered to cover different tissue depths and mechanical demands, as detailed in the technical comparison below:

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8. Ultherapy and Ultherapy PRIME: November 2025 Clearances

Ultherapy is a non-invasive skin tightening device that uses Microfocused Ultrasound with Visualization (MFU-V) to deliver energy to the SMAS layer. This mimics the target layer of a surgical facelift without incisions.

The November 2025 Ultherapy PRIME Body Indication

Ultherapy PRIME first launched in the U.S. in 2024 as the next-generation microfocused ultrasound platform. In November 2025, Merz announced an FDA clearance expanding Ultherapy PRIME's indications to the body — the most significant update since launch, featuring redesigned transducer handpieces, a faster operating system, and new anatomical clearances:

• New Clearances: The FDA expanded Ultherapy PRIME's indications to include the treatment of skin laxity on the anterior arms, posterior arms, and abdomen.
• Visualization System: Ultherapy PRIME maintains the "See and Treat" safety standard, allowing providers to visualize the tissue layers down to 4.5mm in real-time to avoid treating bone or major blood vessels.

Clinical Treatment Maps and Dosing Protocols

The clinical application of Ultherapy PRIME utilizes standard treatment maps detailing line counts and energy levels:

• Full Face & Upper Neck (800 Lines): Typically distributed as 280 lines with the 4.5mm transducer (at 0.45 Joules), 320 lines with the 3.0mm transducer (at 0.30 Joules), and 200 lines with the 1.5mm transducer (at 0.18 Joules).
• Anterior & Posterior Arms (600 Lines total): Distributed as 150 lines per arm using the 3.0mm transducer and 150 lines using the 1.5mm transducer to target dermal skin laxity above the triceps.
• Abdomen (800 Lines total): Utilizing the 4.5mm and 3.0mm transducers to target postpartum skin laxity or post-weight loss tissue changes.

Transducer Frequency and Depth Selection Criteria

Ultherapy PRIME uses specific transducers to target distinct tissue layers, creating microscopic thermal coagulation zones (TCZs) at precise depths without damaging the intervening skin:

• DS 4-4.5 (4 MHz, 4.5mm Depth): Targets the Superficial Muscular Aponeurotic System (SMAS) and deep fascial layers. The lower frequency (4 MHz) allows deep acoustic energy penetration to stimulate structural contraction.
• DS 7-3.0 (7 MHz, 3.0mm Depth): Targets the deep reticular dermis and subdermal fat interface, stimulating type I and type III collagen synthesis to increase skin thickness and density.
• DS 7-1.5 (7 MHz, 1.5mm Depth): Targets the superficial papillary/reticular dermis to smooth fine lines and address superficial crepey texture.
• DS 10-1.5 (10 MHz, 1.5mm Depth): A high-frequency, shallow-depth transducer optimized for thin, delicate skin structures (e.g., periorbital and perioral zones), minimizing the risk of superficial blistering by confining energy to the upper dermis.

Transducer Quality, Calibration, and Staff Safety

To maintain treatment consistency and prevent injuries, clinical facilities must establish operational protocols for Ultherapy systems:

• Calibration Testing: Ultherapy PRIME features an automated startup calibration check. Transducers must deliver energy within a strict +/- 10% thermal window. Any transducer failing calibration must be quarantined immediately to prevent uneven tissue heating.
• Staff Safety: Unlike RF or laser systems that present eye injury hazards, ultrasound energy does not scatter in air. Therefore, protective eyewear is not required for operators. However, staff must avoid placing fingers in the path of the transducer face during activation, as this can cause deep thermal bone burns.
• Transducer Longevity: Transducers are coded with a finite line count (typically 2400 lines). Once the line count is exhausted, the transducer must be replaced to ensure that the acoustic lenses have not degraded, which would alter focal depth accuracy.

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9. Clinical Trial Milestones: Evidence for Approvals

To support its regulatory filings, Merz Aesthetics has completed multiple clinical trials establishing safety and efficacy benchmarks.

Xeomin Glabellar Lines Phase III Clinical Trials

The clinical program supporting Xeomin's cosmetic approval (BLA 125360) consisted of two identical, multicenter, randomized, double-blind, placebo-controlled trials enrolling a total of 547 healthy adult patients.

• Efficacy Endpoints: The primary endpoint was the proportion of patients achieving a composite success rate at day 30, defined as an Investigator Global Assessment (IGA) score of 0 or 1 (none or mild) and a 2-grade improvement from baseline on a 5-point facial wrinkle scale, verified by patient self-assessments. In Study 1, 60% of Xeomin patients met this criteria compared to 0% of placebo patients. In Study 2, 48% of Xeomin patients met the primary endpoint compared to 0% of placebo.
• Safety Profile: The most common adverse events reported by patients receiving Xeomin were headache (5.4%), nasopharyngitis (3.7%), injection site pain (2.2%), and eyelid ptosis (1.8%).

Radiesse for Décolleté Wrinkles (P050052/S162)

The clinical study that supported the March 2026 FDA approval was a randomized, controlled, evaluator-blinded, multicenter trial enrolling 152 women aged 30 to 65 with moderate to severe décolleté wrinkles, randomized to immediate Radiesse treatment (n = 116) or a delayed-treatment control (n = 36).

• Efficacy Endpoints: The primary endpoint was the proportion of treated patients achieving at least a 1-point improvement on the validated Merz Aesthetic Scale at week 24 (6 months), which was significantly greater than the control group. Patient-reported outcomes showed more than 80% satisfaction with skin tightness, and roughly 90% of evaluators observed visible improvement by 4 months; 83% of patients were willing to repeat treatment at one year.
• Safety Profile: The most common adverse events recorded were injection site bruising, redness, swelling, and transient tenderness. Localized reactions were mild to moderate and resolved within the typical post-treatment window. (An FDA advisory panel in August 2025 had flagged theoretical concerns about nodule formation and interference with breast imaging, which is why the labeled indication specifies trained, anatomically precise subdermal injection.)

Belotero Balance Pivotal Clinical Trial

The registration trial for Belotero Balance (P090016) was a split-face, multicenter, evaluator-blinded comparison against Restylane in 118 subjects.

• Efficacy Endpoints: The trial assessed the correction of nasolabial folds at 24 weeks using the Wrinkle Severity Rating Scale (WSRS). The study demonstrated that Belotero was non-inferior to Restylane, with 89% of subjects maintaining a 1-grade or greater improvement.
• Safety Profile: Subject diaries reported significantly less local pain and swelling with Belotero immediately post-injection, confirming its soft integration.

Ultherapy PRIME for Skin Laxity (510(k) K243035)

The November 2025 clearance for arms and abdomen was supported by a literature-based clinical evaluation rather than a single new randomized trial (per the 510(k) substantial-equivalence pathway, cleared February 24, 2025).

• Efficacy Endpoints: Seven published clinical studies of the Ulthera system were identified, evaluating 54 subjects for the abdomen (across 3 studies) and 113 subjects for the arms (across 5 studies). These studies demonstrated clinically significant skin improvement up to 180 days post-treatment via blinded clinician photographic assessment and physician/subject Global Aesthetic Improvement scales.
• Safety Profile: Transient erythema and mild swelling were the most common reactions. Real-time visualization (DeepSEE) is designed to prevent bone contact or thermal burns, and the studies showed no persistent nerve injuries.

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10. Adverse Events: Analysis of the FDA MAUDE Database

A search of the FDA MAUDE database reveals a stable safety profile for Merz's device portfolio.

Radiesse Adverse Events

• Total MAUDE Records: 1,588
• Injury Reports: 1,216
• Malfunction Reports: 3
• Other/Unspecified: 365

The adverse event profile for Radiesse reflects its calcium hydroxylapatite composition:

1. Nodules and Lumps: Because CaHA is a particulate biostimulator rather than a smooth HA gel, improper injection technique (such as superficial placement or lack of post-injection massage) can result in firm nodules.
2. Delayed Inflammatory Nodules: Unlike HA fillers, Radiesse cannot be dissolved using hyaluronidase. Treatment of CaHA nodules requires mechanical disruption, steroid injections, or waiting for natural biodegradation (typically 12 to 18 months).
3. Vascular Events: As with all injectables, vascular occlusion is a risk. Because Radiesse cannot be chemically dissolved, injectors must use precise technique—such as blunt-tip cannulas and low-pressure aspiration—to avoid intravascular placement.

Ultherapy Adverse Events

• Total MAUDE Records: 162
• Injury Reports: 145
• Malfunction Reports: 17

The low volume of Ultherapy reports in MAUDE (162 total reports over its lifecycle) reflects its established safety profile. Reported injuries include:

• Transient swelling and erythema (redness): Standard post-treatment responses resolving within 72 hours.
• Superficial burns and striping: Caused by poor transducer contact with the skin, resulting in ultrasound energy dispersing too superficially.
• Transient nerve neuropraxia: Numbness or motor weakness caused by treating directly over the marginal mandibular nerve or supraorbital nerve. Ultherapy PRIME's real-time visualization is designed to prevent these injuries.

MAUDE Adverse Event Distribution
Radiesse (1,588 total reports)
  ├── Injury (Nodules, swelling): 1,216 (76.6%)
  ├── Other (Delayed response): 365 (23.0%)
  └── Malfunction: 3 (0.4%)

Ultherapy (162 total reports)
  ├── Injury (Burns, nerve numbness): 145 (89.5%)
  └── Malfunction (Calibration error): 17 (10.5%)

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11. FDA Recalls: Historical Database Review

The FDA recalls database lists 5 recalls matching Merz Aesthetics and its Ulthera subsidiary. All five are Class II (moderate risk) and have been officially terminated:

1. Radiesse Volume Advantage 1.5 CC (2011): A syringe/part-number recall involving specific lot numbers of the Radiesse Volume Advantage configuration.
2. Radiesse 1.3cc Syringe (2011): A recall of specific lots (manufactured by BioForm Medical) tied to sterilization/use-dating concerns.
3. Radiesse (+) Lidocaine 1.5cc (2015 and 2016): Two separate labeling/lot actions on the lidocaine-mixed Radiesse configuration.
4. Ulthera Cellfina Prep Pack (2016): A recall of the Cellfina Prep Pack accessory (Part No. CP1) distributed by Ulthera, Inc.

Notably, all five recalls involve injectable fillers or accessories rather than the Ultherapy ultrasound platform itself — the Ultherapy device has no recalls in the database.

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12. FAQs

Can Radiesse be dissolved if a complication occurs?

No. Unlike hyaluronic acid fillers, which can be dissolved using the enzyme hyaluronidase, calcium hydroxylapatite (Radiesse) cannot be chemically dissolved. Complications such as nodules must be managed with local corticosteroid injections, 5-fluorouracil (5-FU), mechanical disruption, or surgical excision if necessary. This highlights the importance of conservative dosing and precise injection depth.

What is the difference between Ultherapy and Ultherapy PRIME?

Ultherapy PRIME is the next-generation platform cleared in November 2025. It offers a 20% faster treatment speed, a larger high-definition touch screen, improved real-time visualization software, and redesigned transducer handpieces that improve skin contact and energy delivery. It also holds expanded clearances for the arms and abdomen.

Why is Xeomin referred to as a "naked" neurotoxin?

Xeomin is called "naked" because its manufacturing process removes all accessory (complexing) proteins. It contains only the pure 150 kDa active botulinum toxin type A molecule (incobotulinumtoxinA). This design is intended to prevent the body from developing neutralizing antibodies, which can render botulinum toxin treatments ineffective over time.

What is the recommended hyperdilution ratio for Radiesse in the neck?

The standard recommendation for neck skin tightening is a 1:1 or 1:2 dilution. A 1:1 dilution involves mixing 1.5 mL of Radiesse with 1.5 mL of diluent (sterile saline or saline mixed with 1% lidocaine). A 1:2 dilution involves mixing 1.5 mL of Radiesse with 3.0 mL of diluent. Higher dilution ratios (such as 1:3 or 1:4) are reserved for thin, crepey skin in body areas like the inner arms.

How does the Tyndall effect occur, and how does Belotero prevent it?

The Tyndall effect occurs when a hyaluronic acid filler is injected too superficially, causing light to scatter through the skin and create a bluish discoloration. Belotero Balance prevents this because its patented CPM process creates a gel with varying densities. This allows the filler to spread evenly into the superficial dermis, integrating into the collagen matrix without forming local pools that scatter light.

Is Ultherapy PRIME painful?

Ultherapy energy delivery can cause discomfort as it heats the deep SMAS layer to 60°C–70°C. However, Ultherapy PRIME features an improved energy delivery profile that reduces discomfort compared to the legacy platform. Pain management protocols include oral analgesics, topical numbing creams, and Nitrox (nitrous oxide) if necessary.

How long does Xeomin take to show clinical results?

Xeomin typically begins to show muscle relaxation within 3 to 4 days post-injection, with full clinical results achieved at 14 days. The duration of effect is typically 3 to 4 months, matching the longevity profile of Botox.

Can Radiesse and Belotero be injected in the same treatment session?

Yes. Using different fillers in a single session is a common practice known as "layering." For example, Radiesse can be injected deep on the bone of the cheeks to provide structural volume, while Belotero Balance is injected superficially to treat fine vertical lip lines. Clinicians must verify appropriate depth for each product.

What is the expected lifespan of a reconstituted Xeomin vial?

Once reconstituted with sterile saline, Xeomin should ideally be used within 24 hours. The FDA label recommends storing reconstituted Xeomin in a refrigerator (2°C to 8°C) and using it within 24 hours. However, clinical studies show that reconstituted Xeomin maintains potency and sterility for up to 4 weeks when stored properly.

What are the contraindications for Radiesse injection?

Radiesse is contraindicated for patients with a history of severe allergies or anaphylaxis, hypersensitivity to any of the components (CaHA or CMC), bleeding disorders, or active skin infection at the injection site. It must never be injected into highly vascular areas like the glabella or nose, as this dramatically increases the risk of vascular occlusion and skin necrosis.

How does Xeomin's BLA registration compare to competitors?

Xeomin's BLA 125360 was granted under the US Public Health Service Act. Its manufacturing is subject to the FDA's strict Good Manufacturing Practices (GMP) for biological drugs. The purification process is patented by Merz, distinguishing its regulatory file from Botox Cosmetic (BLA 103000) and Dysport (BLA 125274).

How does Ultherapy PRIME avoid treating bone or nerves?

Ultherapy PRIME uses patented DeepSEE visualization software. The operator can view a real-time ultrasound scan of the skin and subcutaneous layers up to 8mm deep. Nerves and bones are identifiable by their echogenic signatures on the screen, allowing the operator to adjust transducer positioning or energy levels to avoid these structures before launching a treatment line.

What is the clinical significance of Xeomin's dynamic dosing range?

The dynamic dosing range, approved in 2020, allows clinicians to customize Xeomin doses up to 30 units per injection session for glabellar lines based on muscle mass and contraction strength. This flexibility reduces the incidence of under-treatment in patients with highly active frontalis or corrugator muscles, while minimizing the risk of eyelid ptosis by keeping individual injection points tightly controlled (typically 4–6 units per point).

What are the management protocols for delayed onset nodules following Radiesse injection?

Delayed onset nodules (occurring 3–12 months post-treatment) are managed via a step-ladder protocol. First, confirm via ultrasound whether the nodule is inflammatory or a non-inflammatory product accumulation. Non-inflammatory nodules are treated with physical mechanical disruption using a sterile saline/lidocaine injection and vigorous massage. Inflammatory nodules are treated with a combination of intralesional triamcinolone acetonide (TAC, 10–40 mg/mL) mixed with 5-fluorouracil (5-FU) to inhibit fibroblast proliferation and reduce localized chronic inflammation, repeating at 3-week intervals until resolved.

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Sources

1. FDA Premarket Approval (PMA) Database: FDA PMA Search (Referencing PMA P050052 for Radiesse and PMA P090016 for Belotero Balance).
2. FDA Biologics License Application (BLA) Database: FDA Approved Drug Products (Referencing BLA 125360 for Xeomin).
3. FDA 510(k) Premarket Notification Database: FDA 510(k) Search (Referencing clearances for Ultherapy and Ultherapy PRIME under product codes OHV and OUP, including K243035).
4. Merz Aesthetics Press Release (April 2026): FDA Approval of Radiesse for Wrinkles in the Décolleté.
5. Merz Aesthetics Press Release (November 2025): FDA Clearance of Ultherapy PRIME for Arms and Abdomen.
6. FDA Manufacturer and User Facility Device Experience (MAUDE) Database: FDA MAUDE Home (Data extracted and analyzed on June 10, 2026).