Reference
FDA-approved dermal fillers
Every dermal filler the U.S. Food and Drug Administration has approved through premarket approval (PMA) and that is still in force: 17 approvals, with the manufacturer, the material, the date and the uses FDA approved. Each row links to its official FDA record.
Checked against the FDA database on
Before you rely on this list
- FDA approval does not mean a product is still sold in the United States. Some approved fillers have since been discontinued.
- “Approved uses” are the indications in FDA’s approval orders. Use in any other area is off-label.
- A product with the same name bought outside the US supply chain may not be the FDA-approved version. Check the US labeling and the lot number.
| Product | Manufacturer | Material | First approved | Approved uses | FDA record |
|---|---|---|---|---|---|
| Restylane (first approval) | Q-Med AB (Galderma) | Hyaluronic acid |
|
P020023 | |
| Sculptra Sculptra Aesthetic |
Q-Med AB (Galderma) | Poly-L-lactic acid |
|
P030050 | |
| Restylane, Restylane-L Restylane Lyft (formerly Perlane) Restylane Silk Restylane Eyelight |
Q-Med AB (Galderma) | Hyaluronic acid |
|
P040024 | |
| Juvéderm Ultra XC Juvéderm Ultra Plus XC |
Allergan | Hyaluronic acid |
|
P050047 | |
| Bellafill (formerly Artefill) | Tiger Aesthetics Medical | PMMA microspheres in collagen |
|
P020012 | |
| Radiesse (HIV indication) | Merz North America | Calcium hydroxylapatite |
|
P050037 | |
| Radiesse Radiesse (+) |
Merz North America | Calcium hydroxylapatite |
|
P050052 | |
| Belotero Balance Belotero Balance (+) Lidocaine |
Merz North America | Hyaluronic acid |
|
P090016 | |
| Juvéderm Voluma XC Juvéderm Volbella XC Juvéderm Vollure XC Juvéderm Volux XC SKINVIVE by Juvéderm |
Allergan | Hyaluronic acid |
|
P110033 | |
| Restylane Refyne Restylane Defyne Restylane Kysse Restylane Contour |
Q-Med AB (Galderma) | Hyaluronic acid |
|
P140029 | |
| Revanesse Versa (Ultra) Revanesse Versa+ Revanesse Lips+ |
Prollenium Medical Technologies | Hyaluronic acid |
|
P160042 | |
| RHA 2, RHA 3, RHA 4 RHA Redensity RHA Dynamic Volume RHA Redensity Eye Mepi versions (with mepivacaine) |
Teoxane | Hyaluronic acid |
|
P170002 | |
| Evolysse Smooth Evolysse Form |
Symatese | Hyaluronic acid |
|
P240022 | |
| saypha MagIQ | Croma-Pharma | Hyaluronic acid |
|
P240008 | |
| Belotero Volume (+) Lidocaine | Merz North America | Hyaluronic acid |
|
P250020 | |
| saypha ChIQ | Croma-Pharma | Hyaluronic acid |
|
P250021 | |
| Belotero Intense (+) Lidocaine | Merz North America | Hyaluronic acid |
|
P250016 |
Withdrawn approvals
These fillers were approved by FDA, but the approval was later withdrawn, so they can no longer be legally marketed in the United States under that approval.
| Product | Manufacturer | Approved | Approval withdrawn | FDA record |
|---|---|---|---|---|
| Zyderm, Zyplast Cosmoderm, Cosmoplast |
Allergan | P800022 | ||
| Fibrel | Mentor | P850053 | ||
| Hylaform, Hylaform Plus Captique Prevelle Silk |
Genzyme | P030032 | ||
| Hydrelle (Elevess) | Anika Therapeutics | P050033 | ||
| Evolence | Colbar Lifescience | P070013 |
How to check a filler yourself
- Search the FDA PMA database by trade name or PMA number, and compare the approved indications with the product’s labeling.
- Check the box: US labeling, English instructions for use, a lot number and an expiry date.
- Report a suspected counterfeit or a serious adverse event to FDA MedWatch.
Source: FDA premarket approval records, retrieved through openFDA. For information only; not medical or regulatory advice. Trademarks belong to their owners. Aesthetic Harbor is not affiliated with the manufacturers listed.