Dermal filler PMA approvals: who owns the FDA-approved filler market

Dermal fillers are Class III medical devices. In the United States, every filler approved for injection into the face must pass through the FDA's most rigorous device-review pathway — premarket approval (PMA) — before it can be marketed. That process generates a paper trail: original PMA applications for new products, and hundreds of supplements for manufacturing changes, new indications, and formulation updates.

An analysis of 1,036 PMA records under product code LMH ("Implant, Dermal, For Aesthetic Use") in the FDA PMA database — spanning from the first collagen filler approved in 1981 through May 2026 — reveals how the dermal-filler market consolidated around a few major applicants, which products have generated the most regulatory activity, and what the recent wave of new approvals means for patients and providers.

How dermal fillers are regulated

The FDA classifies dermal fillers as Class III devices, the highest-risk category for medical devices. Unlike the 510(k) clearance pathway used for most aesthetic energy-based devices — which requires only a showing of "substantial equivalence" to a previously cleared device — PMA requires the manufacturer to submit clinical data demonstrating safety and effectiveness.

Product code LMH covers all dermal fillers for aesthetic facial use. A separate code, PKY, covers dermal fillers for hand augmentation. Each new filler requires its own original PMA application with clinical trial data. Once a filler has its original PMA, the manufacturer files supplements for changes: new indications (e.g., adding lip augmentation to a filler originally approved for nasolabial folds), manufacturing process changes, formulation updates, and labeling revisions.

The 20 original filler PMA approvals

Since the first collagen-based dermal filler (Zyderm) was approved in 1981, the FDA has granted only 20 original PMA approvals for new dermal filler products. That number is striking in an industry that feels crowded — it means every filler syringe in a US provider's office traces back to one of just 20 regulatory lineages.

The collagen era (1981–2004)

The first generation of fillers was collagen-based:

• Zyderm (Allergan, P800022) — approved 1981. Bovine collagen. The first injectable dermal filler approved in the US. Required skin testing before use because of bovine-protein allergy risk. No longer marketed.
• Fibrel (Mentor, P850053) — approved 1988. Also no longer marketed.
• CosmoDerm / CosmoPlast (Allergan, supplement to P800022) — human-derived collagen, approved 2003. No longer marketed.

These products lasted approximately 2–3 months and required allergy testing. They established the regulatory framework but have been fully supplanted by longer-lasting materials.

The HA revolution (2003–2017)

Hyaluronic acid (HA) fillers transformed the market beginning with Restylane's approval in December 2003:

The new entrants (2025–2026)

After a gap of nearly eight years with no new original PMA approvals, three new fillers entered the market in rapid succession:

• Evolysse Smooth and Evolysse Form (Symatese, P240022) — approved February 13, 2025. Developed by French biomaterials company Symatese using COLD-X™ technology and marketed in the US by Evolus. Indicated for correction of moderate to severe dynamic facial wrinkles and folds. A pivotal trial of 140 patients demonstrated non-inferiority to Restylane-L, with statistically significant superiority (p < 0.001).
• saypha MagIQ (Croma-Pharma, P240008) — approved September 8, 2025. An HA filler developed by Austrian company Croma-Pharma and marketed under the Obagi Medical brand by Waldencast. Backed by a 270-patient pivotal study for nasolabial fold correction. Uses proprietary MACRO Core Technology for 3D HA matrix formation. Commercial US launch planned for 2026.
• Belotero Volume (+) Lidocaine (Merz, P250020) — approved May 19, 2026. A midface volumizer adding lidocaine to the Belotero family. Merz's fourth original PMA, making it tied with Q-Med AB (Galderma) for the most original filler approvals.

The Evolus/Symatese partnership is especially notable: Evolus has also submitted a PMA for Evolysse Sculpt, a midface volumizer, with FDA approval expected in the second half of 2026. If approved, it would position Evolus as a full-portfolio filler competitor.

Who owns the PMA landscape

By number of original PMA approvals, the applicant leaderboard is:

But original PMA counts understate the picture. The total number of PMA records — original approvals plus all supplements — reveals how much ongoing regulatory activity each product generates:

Radiesse alone has generated 315 PMA records across two related applications — the most of any filler family. The Juvéderm family (P050047 + P110033) collectively accounts for 195 records.

What supplements reveal: the indication-expansion timeline

Of the 1,036 total PMA records, 149 are labeling supplements that expanded approved indications or updated instructions. These supplements map the industry's shift from "wrinkle filling" to full facial contouring:

• 2006–2012: Supplements focused on lidocaine integration (making treatments more comfortable) and adding Perlane/Restylane-L variants.
• 2013–2017: The midface-volumizer era. Juvéderm Voluma XC (2013) was the first filler approved specifically for age-related volume loss in the cheeks. Supplements followed for chin augmentation (Voluma, 2020) and jawline contouring (Volux XC, 2022).
• 2018–2023: Lip, infraorbital, and temple augmentation. Restylane Silk (lips), Restylane Eyelight (infraorbital hollows), and Restylane Contour (temple) expanded treatment beyond the nasolabial folds. RHA 3 gained lip indication (2023). Skinvive by Juvéderm introduced a skin-booster concept (2023).
• 2024–2026: Continued indication expansion and new entrants. RHA Dynamic Volume (2025), Belotero Balance (+) Lidocaine expanded labeling (2025), and Radiesse received a jawline indication supplement (2026).

Three entirely new anatomic indications were approved between 2021 and 2025: infraorbital hollowing, jawline augmentation, and temple augmentation. The FDA convened a General Issues Panel meeting on dermal fillers in August 2025 specifically to discuss safety considerations as fillers move into new facial zones and body areas.

What this means for patients

Understanding the PMA landscape matters for patients in several practical ways:

"FDA approved" has a specific meaning for fillers. Unlike energy-based devices that are "cleared" through 510(k), every dermal filler in the US has been through the PMA process with clinical trial data. This is a higher evidentiary bar.

New does not mean better. The three newest entrants (Evolysse, saypha MagIQ, Belotero Volume) are approved for nasolabial folds and midface volume — the same indications that established fillers have covered for years. Their differentiation is in crosslinking technology, tissue integration, and manufacturing, not in new treatment capabilities. A provider's experience with a specific product often matters more than the product's launch date.

The market is widening. For nearly a decade (2017–2025), no new company received an original filler PMA. The 2025 approvals from Symatese/Evolus and Croma-Pharma/Obagi introduce new competitors — which may eventually affect pricing and access, though the market impact will take years to materialize.

Indication expansion is not automatic. Each new anatomic area (lips, cheeks, chin, jawline, temples, infraorbital) required a separate supplement with clinical data. When a provider uses a filler off-label — in an area not listed on the approved indication — the clinical evidence base may be thinner. Ask your provider whether the planned injection site is an FDA-approved indication for the specific filler being used.

HA fillers are reversible; others are not. Of the 20 original PMA products, the vast majority are hyaluronic acid fillers, which can be dissolved with hyaluronidase if there is a complication. Radiesse (CaHA), Sculptra (PLLA), and Bellafill (PMMA) are not reversible. This distinction is particularly important for patients considering treatment in high-risk areas like the nose or tear troughs.

What to ask your provider

• Which specific filler product will be used, and is the injection site an FDA-approved indication for that product?
• How long has the provider been injecting this specific product (not just fillers in general)?
• Is the filler HA-based, and therefore reversible with hyaluronidase?
• Has the filler's PMA number been updated recently? (New supplements may reflect updated safety labeling.)

The FDA maintains a searchable PMA database at accessdata.fda.gov where any patient or provider can look up the full approval history for a specific filler by product name or PMA number.

Sources

• FDA PMA Database — search by product code LMH: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm
• FDA Executive Summary, General Issues Panel Meeting on Dermal Fillers (August 2025): https://www.fda.gov/media/188185/download
• FDA Dermal Fillers (Soft Tissue Fillers) page: https://www.fda.gov/medical-devices/aesthetic-cosmetic-devices/dermal-fillers-soft-tissue-fillers
• FDA Clinical Overview of Dermal Fillers: https://www.fda.gov/media/147036/download
• Evolysse Smooth/Form SSED (P240022): https://www.accessdata.fda.gov/cdrh_docs/pdf24/P240022B.pdf
• Symatese press release on Evolysse FDA approval: https://www.symatese.com/wp-content/uploads/2025/02/Press-Release_PMA_EVOLYSSE_FEB-2025.pdf
• Croma-Pharma saypha MagIQ FDA approval announcement: https://www.cromapharma.com/assets/downloads/croma-pharma-gmbh-celebrates-fda-approval-of-obagi-saypha-magiq-in-the-united-states/Croma-PR-FDA-Approval-MagIQ-ENG.pdf
• Waldencast FDA approval SEC filing: https://www.sec.gov/Archives/edgar/data/1840199/000134100425000082/ex99-1.htm Analysis sample: FDA PMA database extract dated 2026-06-10, 1,036 PMA records under product code LMH (Implant, Dermal, For Aesthetic Use), including 20 original approvals and 1,016 supplements. Analysis by AestheticMedGuide.