InMode Aesthetic Device Footprint: RF Platform Clearances and Adverse-Event Context

What does the public regulatory data reveal about InMode and its aesthetic device portfolio, and what should a buyer, medical director, clinical operator, or regulatory affairs team do with it?

Analysis of the FDA medical device databases reveals that InMode holds a highly specialized regulatory footprint in radiofrequency (RF) aesthetic technologies. This dossier aggregates and analyzes InMode's 8 FDA 510(k) clearances in our GEX/ONF database slice—led by the "InMode Multi-system" (K221571) and the "Optimas MAX System" (K251632) cleared in June 2025—alongside its product-code classification architecture, historical recalls (zero recalls in our registry slice), and post-market safety context, including the FDA's class-wide October 2025 RF microneedling safety communication.

For clinical buyers and practice managers, this guide demystifies InMode's modular console engineering, maps its clearances across FDA product codes (GEX vs. GEI vs. OUYH), parses its MAUDE database records, and provides practical risk-mitigation protocols for its flagship applicator, Morpheus8.

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1. Corporate History and the Rise of Radiofrequency Aesthetics

Founded in 2008 in Israel by Dr. Michael Kreindel and Moshe Mizrahy, InMode Ltd. (originally known as Invasix Ltd.) was established to pioneer minimally invasive and non-invasive radiofrequency (RF) technologies for medical aesthetics. The founders had a deep pedigree in aesthetic engineering; Dr. Kreindel had previously co-founded Syneron Medical and co-developed elōs (Electro-Optical Synergy) technology.

• Minimally Invasive Beginnings (2008–2012): InMode focused on RF-Assisted Lipolysis (RFAL), developing patented handpieces (BodyTite and FaceTite) designed to melt subcutaneous fat while simultaneously tightening the overlying skin.
• The Multi-System Modular Pivot (2013–2018): InMode launched modular consoles—including the InMode Multi-system, Optimas, and Triton—that allowed clinics to attach multiple handpieces (such as Lumecca IPL, Diolaze hair removal, and Forma skin tightening) to a single generator.
• NASDAQ IPO and Rapid Expansion (2019): InMode went public on the NASDAQ exchange in August 2019, raising capital to scale its commercial footprint and expand its clinical indications.
• The Morpheus8 Phenomenon (2020–2024): InMode achieved massive commercial success with Morpheus8, a subdermal adipose remodeling device (SARD) that combined microneedling with fractional RF energy, becoming one of the most widely requested skin treatments.
• The Optimas MAX and Next-Gen Consoles (2025–2026): In June 2025, InMode received FDA clearance for the Optimas MAX console, updating its generator architecture to support higher peak energy levels and faster handpiece duty cycles.

These corporate milestones established InMode as a dominant force in RF aesthetics, backed by a unique modular regulatory framework.

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2. InMode's 510(k) Clearance and Product-Code Map

A clinical buyer researching InMode must understand the distinction between InMode's cleared consoles (which generate the energy) and its cleared applicators (which deliver the energy). The FDA regulates these consoles under different product codes depending on their energy source and intended use.

The GEX vs. GEI vs. OUYH Code Map

In InMode's regulatory architecture, devices are split across three primary FDA product codes:

1. GEX (Laser instrument, surgical): Cleared under 21 CFR 878.4810. InMode's multi-application consoles (such as the InMode Multi-system K221571 and Optimas MAX K251632) are cleared under this code because they contain optical/IPL generators (like Lumecca) alongside RF circuits.
2. GEI (Electrosurgical device and accessories): Cleared under 21 CFR 878.4400. InMode's minimally invasive RFAL platforms (BodyTite K171593 and FaceTite K151793) are cleared under this code because they deliver high-frequency electrical current to cut, coagulate, and ablate tissue.
3. OUYH (Electrosurgical device for aesthetic use): Cleared under 21 CFR 878.4400. This specialized aesthetic code covers non-invasive and fractional RF devices like Morpheus8 (K200947, K240017) and Forma.

Selected InMode FDA 510(k) Clearances

To illustrate InMode's regulatory timeline, the following table lists representative clearances spanning their primary technology pillars:

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3. Core Platforms: Morpheus8, BodyTite, FaceTite, Lumecca, and Forma

InMode’s clinical reputation and market presence are defined by its specialized applicators, which target skin remodeling, fat reduction, skin tightening, vascular lesions, and hair removal:

Morpheus8: Subdermal Adipose Remodeling Device (SARD)

Morpheus8 is a fractional RF microneedling platform that targets skin laxity, wrinkles, acne scars, and fat remodeling.

• Fractional Depth Control: The needle depth is adjustable from 1.0mm to 4.0mm (plus an additional 1.0mm thermal profile) for facial treatments. The Morpheus8 Body handpiece penetrates up to 7.0mm (plus a 1.0mm thermal profile) to target subcutaneous fat.
• Insulated Needles: The needles are insulated with a medical-grade coating except for the active tip. This spares the epidermis from thermal damage while delivering a concentrated RF pulse directly to the deep dermis or subdermal fat.
• The July 2024 Tissue Contraction Clearance (K240017): In July 2024, InMode received a specific FDA clearance (K240017) confirming that Morpheus8 is indicated for soft tissue contraction. This allows the company to market the SARD platform specifically for tightening loose skin. For a focused look at the most discussed Morpheus8 complication and how to avoid it, see our Morpheus8 fat-loss risk guide.

BodyTite & FaceTite: RF-Assisted Lipolysis (RFAL)

BodyTite and FaceTite are minimally invasive, surgical procedures performed under local tumescent anesthesia.

• Dual-Electrode Mechanism: The technology uses a two-pronged handpiece: an internal cannula (electrode) is inserted under the skin through a small incision, while an external electrode slides along the skin surface.
• Controlled Thermal Field: High-frequency electrical current travels between the internal and external electrodes. This heats the subcutaneous fat to a target temperature of 60°C to 70°C (inducing immediate lipolysis) while maintaining the overlying skin surface temperature at a safe range of 38°C to 40°C.
• Immediate Skin Contraction: The thermal energy coagulates small blood vessels (reducing bruising) and contracts the fibrous septae network, causing immediate skin tightening.

Forma & Forma Plus: Non-Invasive Skin Tightening

Forma is a non-invasive skin tightening treatment that targets skin laxity on the face and neck.

• Bipolar Radiofrequency: Forma uses bipolar RF electrodes to heat the skin uniformly. Bipolar RF flows between the positive and negative poles in the handpiece, targeting the dermis.
• A.C.E. (Acquire, Control, Extend) Technology: Forma features an integrated sensor that reads the skin surface temperature 1,000 times per second. When the skin reaches the target therapeutic range (41°C to 43°C), the system automatically reduces or cuts RF power to prevent burns, allowing the operator to safely extend the time spent in the therapeutic temperature range.

Lumecca: High-Peak-Power Intense Pulsed Light (IPL)

Lumecca is a high-power IPL handpiece used to treat pigmentation, sun damage, vascular redness, and rosacea.

• Peak Power Output: Lumecca delivers a peak power of 3.3 kW/cm², which is significantly higher than standard IPL systems. This high peak power targets melanin and oxyhemoglobin efficiently, requiring fewer sessions to clear pigmentation.

Diolaze & DiolazeXL: Diode Laser Hair Removal

Diolaze is an integrated laser hair removal handpiece built for the multi-system console.

• 810nm Diode Laser Wavelength: The 810nm wavelength is absorbed by melanin in the hair shaft, traveling down to the hair bulb to induce thermal destruction.
• 3D Contact Cooling: Diolaze features a sapphire cooling plate that cools the skin before, during, and after the laser pulse, providing comfort during high-energy treatments.

Vasculaze: Nd:YAG Vascular Handpiece

Vasculaze is a dedicated vascular handpiece cleared for treating spider veins, telangiectasias, and angiomas.

• 1064nm Wavelength: The long-pulse Nd:YAG wavelength targets hemoglobin, coagulating spider veins on the face and legs.

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4. Clinical Protocols and Technical Specifications

Clinical success and safety with InMode systems require adjusting parameters—pulse energy, needle depth, RF mode, and surface temperature limits—to the patient's skin type and anatomical zone.

The following clinical parameters settings matrix outlines representative settings for InMode workstations:

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5. RF Microneedling Safety: The October 15, 2025 FDA Safety Communication

On October 15, 2025, the U.S. Food and Drug Administration (FDA) issued a class-wide Safety Communication warning patients and healthcare providers about the potential risks associated with radiofrequency (RF) microneedling devices. For our standalone analysis of this class-wide alert and what it means for every RF microneedling platform, see our FDA RF microneedling safety warning explainer.

Summary of the FDA Alert

• Purpose: The FDA issued the alert to make the public aware of a post-market safety signal: reports of serious, localized complications linked to RF microneedling procedures.
• Reported Complications: The communication detailed adverse events including:
  • Thermal Burns and Blisters: Caused by excessive RF energy levels or poor handpiece coupling.
  • Lipoatrophy (Fat Loss): Unintended fat loss occurring when needles penetrate too deeply into the subcutaneous fat layer (e.g., using Morpheus8 facial settings at 4.0mm on thin-skinned areas), melting structural fat and causing facial hollowing.
  • Permanent Scarring and Disfigurement: Severe burns leading to localized scarring or texture changes.
  • Nerve Damage: Thermal injury to superficial facial nerves (such as the marginal mandibular nerve), causing temporary or permanent facial asymmetry.
• Administrative Clarification: The FDA emphasized that RF microneedling is a medical procedure, not a cosmetic spa treatment, and must only be performed by trained, licensed healthcare professionals.

Biomechanical Risk Analysis: Marginal Mandibular Nerve and Lipoatrophy

• Marginal Mandibular Nerve Vulnerability: The marginal mandibular branch of the facial nerve runs along the lower border of the jawline, superficial to the masseter muscle. In thin patients, this nerve lies only 2.0mm to 3.5mm beneath the skin surface. Using deep needle settings (e.g., 3.0mm to 4.0mm) combined with high RF energy levels along the jawline can cause direct thermal injury to this nerve, resulting in temporary or permanent oral asymmetry (drooping of the lower lip).
• Pathology of Lipoatrophy: Subcutaneous fat is divided into superficial and deep fat pads. The superficial fat pads of the midface provide volume and structure. When fractional RF needles penetrate past the dermis into the superficial fat pads, the thermal energy melts the adipocytes. Uncontrolled thermal lipolysis leads to localized hollowing (lipoatrophy) and can accelerate facial aging.

Clinical Risk Mitigation for Morpheus8

To align with the 2025 FDA Safety Communication, clinical operators must implement strict safety protocols:

• Avoid Over-penetration in Thin-Skin Zones: Never use needle depths exceeding 1.5mm over the forehead, temples, or periorbital area, where the subcutaneous layer is extremely thin. Deep settings in these zones can damage superficial facial nerves or fat pads.
• Ensure Flat Applicator Coupling: The operator must press the handpiece tip flat against the skin before firing. Poor coupling can cause the electrical current to arc at the skin surface, creating localized epidermal burns and scarring.
• Avoid Overlapping Pulses: Do not deliver overlapping pulses in a single pass. Overlapping accumulates heat rapidly in the tissue, exceeding the safe thermal threshold and increasing the risk of burns and PIH.
• Post-Treatment Cooling: Apply cold compresses or a soothing ointment immediately after treatment, but avoid ice packs directly on the skin to prevent cryo-burns on compromised tissue.

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6. InMode's FDA Recalls: Historical Database Review

Analyzing a manufacturer's recall history provides clinical buyers with objective data regarding manufacturing quality, component durability, and software reliability. An examination of the FDA recall database shows that InMode has 0 recalls listed in our device registry slice, indicating a clean manufacturing track record for their cleared consoles and handpieces.

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7. Adverse Events: Analysis of the FDA MAUDE Database

The FDA’s MAUDE database compiles reports of medical device malfunctions, injuries, and deaths. It is a critical post-market surveillance tool, though it cannot establish clinical incidence rates due to under-reporting and lack of denominator data (total treatment volumes).

A search of the FDA MAUDE database summary reveals 22 reports associated with InMode devices in the slice:

• Injury Reports: 15
• Malfunction Reports: 7
• Death Reports: 0 (Unlike invasive surgical energy systems, InMode's aesthetic portfolio shows zero death reports in the registry).

Event Distribution by Brand

1. Solaria CO2 Laser System: 7 reports (Legacy carbon dioxide laser system)
2. Vasculaze: 3 reports (Nd:YAG vascular handpiece)
3. Lumecca: 3 reports (IPL handpiece)
4. InMode Multi-system: 1 report
5. Optimas MAX: 1 report
6. Morpheus 8: 1 report
7. Morpheus 8 Body Handpiece: 1 report
8. Diolaze System: 1 report

MAUDE Adverse Event Distribution
InMode (22 total reports, by manufacturer in slice)
  ├── Injury: 15 (68.2%)
  └── Malfunction: 7 (31.8%)

Key Clinical Safety Analysis

• Solaria CO2 Laser System: The Solaria CO2 laser was a legacy ablative platform. Reports describe typical ablative complications, including prolonged healing times, localized burns, and scarring.
• Morpheus8 and Morpheus8 Body (RF Microneedling): Reports describe technique-dependent burns caused by poor coupling and localized lipoatrophy caused by using settings that are too deep for the target anatomical zone.
• Reporting Ratios and Surveillance Limits: While the MAUDE search returns only 22 reports in the slice, this number represents only a fraction of clinical incidents. In the aesthetic medical community, minor complications such as temporary PIH or moderate blistering are rarely reported to the FDA by clinics or patients, as they resolve without surgical intervention.

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8. InMode's Hands-Free RF Platforms: EvolveX and Evoke

In addition to modular consoles and surgical handpieces, InMode holds a significant presence in hands-free tissue remodeling through its Evolve and Evoke platforms:

Evoke: Hands-Free Facial Remodeling

Evoke is a hands-free workstation cleared for facial skin tightening and submental contouring.

• Hands-Free Applicators: The platform utilizes headbands that secure bipolar RF applicators to the cheeks and submental area.
• Continuous Temperature Monitoring: Like Forma, Evoke applicators measure skin impedance and surface temperature continuously, maintaining the skin within a therapeutic range of 42°C to 43°C to stimulate dermal remodeling while preventing epidermal burns.

Evolve & EvolveX: Multi-Modal Body Contouring

EvolveX is a hands-free body contouring platform that integrates three distinct modalities:

• Tite (Skin Tightening): Delivers bipolar RF energy through surface applicators to heat the dermis, targeting loose skin on the abdomen, arms, and thighs.
• Tone (Muscle Stimulation): Delivers electrical muscle stimulation (EMS) to target specific muscle groups, inducing involuntary muscle contractions that build tone and strength.
• Transform (Combination Therapy): Combines bipolar RF (for skin tightening and fat heating) with EMS (for muscle stimulation) in a single applicator, allowing for dual muscle-dermal remodeling in a single session.

The following table details the parameters and clinical objectives of the EvolveX treatment modes:

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9. Clinical Trial Milestones: Evidence for Approvals

InMode's FDA clearances are supported by clinical trials that establish safety and efficacy parameters:

Morpheus8 Soft Tissue Contraction Clearance (K240017)

• Study Design: A multi-center prospective study evaluated the safety and efficacy of the Morpheus8 fractional RF device for the treatment of facial wrinkles and soft tissue laxity.
• Efficacy Endpoints: Efficacy was measured using the Fitzpatrick Wrinkle Assessment Scale (FWAS) and quantitative tissue volume measurements. Subjects received three treatments spaced 4 weeks apart. Blinded evaluations of clinical photographs at 6 months post-treatment showed significant improvement in skin laxity and tissue contraction in over 90% of subjects.
• Safety Profile: Transient erythema, mild swelling, and pinpoint scabbing were common post-treatment, resolving within 3 to 7 days. The use of insulated needles prevented epidermal burns or permanent pigmentary changes, and the trial reported zero cases of scarring or nerve damage.

BodyTite RFAL Clinical Program (K171593)

• Study Design: Clinical trials evaluated the BodyTite system in patients undergoing minimally invasive abdominal and flank contouring.
• Efficacy Endpoints: FAT reduction was measured via ultrasound and clinical photography. At 12 weeks post-treatment, subjects showed significant reduction in fat thickness and measurable skin contraction.
• Safety Profile: Tumescent anesthesia protected deeper tissue. The system's automatic temperature shut-off (stopping RF emission when the skin surface reached 40°C) prevented epidermal burns. Minor bruising and swelling were common, resolving within 2 weeks.

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10. Morpheus8 Clinical Protocols and Technique Guidelines

To ensure patient safety and maximize skin remodeling results, clinical operators must follow a structured treatment protocol:

Step-by-Step Treatment Protocol

1. Patient Selection and Consultation: Evaluate the patient's skin thickness, laxity, and Fitzpatrick skin type. Assess the treatment areas for vulnerable landmarks, such as the jawline (marginal mandibular nerve) and periorbital area.
2. Skin Preparation and Anesthesia: Apply a thick layer of topical anesthetic cream (e.g., compounding BLT—Benzocaine/Lidocaine/Tetracaine) to the treatment zone. Allow it to sit under occlusion (plastic wrap) for 45 to 60 minutes to ensure adequate dermal numbing. Prior to firing the first pulse, remove the anesthetic cream completely, cleanse the skin with a gentle cleanser, and sanitize the surface with a non-alcohol antiseptic solution like chlorhexidine. If alcohol is used, ensure it has completely evaporated to prevent spark ignition. The skin surface must be dry; water or gel will cause electrical arcing.
3. RFID Tip Selection and Test Pulse: Lock the single-use RFID tip cartridge (e.g., 24-pin for face, 40-pin for body) into the handpiece. Program the console's needle depth and RF energy level based on the anatomical zone. Always perform a test pulse in an inconspicuous area (e.g., under the jawline) to verify the patient's tolerance and check the immediate skin response.
4. Applicator Coupling and Stamp Pass: Place the handpiece flat against the skin surface. Apply firm, perpendicular pressure to ensure all needles penetrate uniformly. Press the trigger to deliver the RF pulse. The operator will hear a beep indicating the RF cycle is complete. Move the handpiece to the adjacent zone using a stamp pattern, ensuring a 10% to 15% overlap at the borders to prevent untreated gaps. Never slide or drag the handpiece while the needles are extended.
5. Clinical Endpoint Monitoring: The desired endpoint is immediate, uniform erythema (redness) and mild localized edema (swelling). Pinpoint bleeding at the needle insertion sites is normal and should be gently blotted with sterile gauze. If immediate blistering, severe blanching (whitening), or deep burns occur, stop the treatment, reduce the RF energy, and check the flatness of the handpiece coupling.

Post-Procedure Care and Downtime Management

Patient compliance with post-care instructions is crucial for preventing infection and post-inflammatory hyperpigmentation:

• Immediate Post-Care: Apply a thin layer of a healing ointment (such as Aquaphor or a sterile post-procedure balm) to protect the compromised epidermal barrier. Do not apply makeup or active skincare ingredients (retinols, vitamin C, or exfoliating acids) for at least 72 hours.
• Sun Protection: Instruct patients to avoid direct sun exposure and wear a broad-spectrum mineral sunscreen (SPF 30+) daily starting 24 hours post-treatment. Chemical sunscreens should be avoided for the first 3 days to prevent irritation.
• Healing Timeline: Patients should expect mild-to-moderate redness and swelling for 24 to 72 hours. Pinpoint scabs will form at the needle insertion sites within 2 to 3 days; patients must not scratch or pick these scabs, allowing them to shed naturally to prevent scarring or hyperpigmentation.

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11. Regulatory Compliance and Buying Guide for Practice Managers

For practice managers, medical directors, and laser technicians, purchasing and operating InMode consoles requires a structured compliance and maintenance framework:

Used InMode Console Purchase Checklist

Refurbished InMode consoles (such as Optimas or InMode Multi-system) are highly sought after by med spas. Practice managers should execute this specific quality audit prior to completing a purchase:

Consumable Tips and ROI Calculations

• Consumable Tip Costs: Morpheus8 relies on disposable tip cartridges containing an RFID chip that limits each tip to a single session. Practice managers must factor the cost of these consumable tips (typically $75–$150 per tip) into their pricing and margin calculations.
• RF Grounding Protocols: When performing minimally invasive BodyTite or FaceTite procedures, ensure the patient is in contact with the grounding pad to complete the electrical circuit and prevent electrical shock.

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12. FAQs

Is the Morpheus8 device FDA-cleared?

Yes. The InMode Morpheus8 RF microneedling device is FDA-cleared under product code OUYH as an electrosurgical device for aesthetic use. It holds clearances for the treatment of facial wrinkles, acne scars, and soft tissue contraction.

What is the difference between InMode's GEX and GEI product codes?

GEX is the product code for "Laser instrument, surgical" and covers InMode's multi-application consoles (like Optimas) that include optical or light-based generators. GEI is the product code for "Electrosurgical accessories" and covers InMode's minimally invasive RF-assisted lipolysis devices (like BodyTite and FaceTite) that use high-frequency electrical current.

Are there active recalls for InMode devices in 2026?

According to the FDA database, there are no active, open recalls for InMode devices. The company has a clean manufacturing safety profile with zero recalls listed in our database slice.

How did the October 2025 FDA Safety Communication impact Morpheus8 treatments?

The FDA communication warned of risks like burns, fat loss (lipoatrophy), and nerve damage with RF microneedling. For Morpheus8 treatments, this requires clinics to use conservative settings, avoid excessive needle depths in thin-skin zones (to prevent fat loss and nerve injury), ensure flat handpiece contact (to prevent burns), and restrict treatments to licensed medical professionals.

Can the Lumecca IPL treat vascular redness in rosacea?

Yes. Lumecca is a high-power IPL handpiece that targets hemoglobin in blood vessels. Its high peak power (3.3 kW/cm²) makes it highly effective for resolving diffuse facial redness and spider veins associated with rosacea.

What is the clinical role of the Forma skin tightening handpiece?

Forma is a non-invasive bipolar RF handpiece that heats the dermis to 41°C–43°C to stimulate collagen synthesis. It features integrated temperature sensors that adjust RF output automatically to prevent skin burns.

What are the main contraindications for Morpheus8 treatments?

Morpheus8 is contraindicated for patients with active skin infections, open wounds, pacemakers, or implanted electronic devices in the treatment area. It is also contraindicated for pregnant or lactating patients.

What is the difference between Morpheus8 and Morpheus8 Body?

The standard Morpheus8 handpiece has a maximum needle penetration depth of 4.0mm (plus a 1.0mm thermal profile) and is designed for facial treatments. The Morpheus8 Body handpiece has a larger tip array and penetrates up to 7.0mm (plus a 1.0mm thermal profile) to target subcutaneous fat on the body.

Is EvolveX cleared by the FDA?

Yes. EvolveX is FDA-cleared under product codes GEI (for RF heating) and NGX (for electrical muscle stimulation). It is indicated for non-invasive skin tightening and muscle toning on the abdomen, buttocks, and limbs.

What is Evoke hands-free remodeling?

Evoke is a hands-free, headband-secured bipolar RF workstation cleared for tightening and contouring skin on the cheeks and submental area.

Can Forma be used to treat dry eyes?

Forma is cleared for cosmetic skin tightening. While some clinical practices use it off-label to heat and clear blocked meibomian glands in dry eye disease, this application is considered off-label and requires a distinct clinical protocol.

Can Morpheus8 treat active acne?

Yes. Using insulated needles in monopolar RF mode allows the energy to pass through the epidermis and discharge specifically into hyperactive sebaceous glands in the dermis (typically at 1.5mm–2.5mm depth). This thermal coagulation decreases sebum secretion and destroys Propionibacterium acnes bacteria, resolving active inflammatory lesions.

What are the consumable tip configurations for Morpheus8?

Morpheus8 tips are available in three main configurations: the 24-pin tip (dermal remodeling), the 12-pin Prime tip (for small, delicate zones like the periorbital or perioral areas), and the 40-pin Body tip (for larger body zones and deeper subdermal fat remodeling). All cartridges contain an RFID chip that limits each tip to a single session.

What are the common side effects of EvolveX treatments?

Common side effects include transient skin redness, mild localized swelling, and temporary muscle soreness (similar to the feeling after an intense workout) from the EMS stimulation. Rare complications include superficial skin burns if EvolveX Tite applicators lose flat skin contact.

How does the Optimas MAX console improve over legacy Optimas?

The Optimas MAX system, cleared under K251632 in June 2025, features an upgraded RF generator that delivers higher peak power, faster heating cycles, and support for next-generation MAX handpieces (such as Lumecca MAX and Morpheus8 MAX), which reduce treatment times and improve temperature calibration.

Can Morpheus8 treat submental fat (double chin)?

Yes. Using needle depths of 3.0mm to 4.0mm allows the RF energy to target the submental fat pad, inducing localized fat cell coagulation and contraction of the overlying skin. However, settings must be adjusted carefully in thin patients to prevent superficial nerve injury.

What is the clinical role of the Vasculaze handpiece?

Vasculaze is a long-pulse Nd:YAG handpiece operating at 1064nm. It is cleared for treating vascular lesions, telangiectasias, and spider veins on the face and legs, targeting hemoglobin to coagulate and clear damaged vessels.

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Sources

1. FDA 510(k) Premarket Notification Database: FDA 510(k) Search Tool (Referencing clearances K251632 for Optimas MAX, K240017 and K200947 for Morpheus8, and K171593 for BodyTite).
2. FDA Safety Communications: FDA Safety Communication: Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling (Official Safety Communication issued by the FDA, dated October 15, 2025).
3. FDA Manufacturer and User Facility Device Experience (MAUDE) Database: FDA MAUDE Search Tool (Extracted and aggregated data for InMode Ltd. / Invasix devices).
4. InMode Clinical and Technical Publications: InMode Medical Aesthetics (Prescribing information, modular console specifications, and Morpheus8 depth/energy settings).