Identity
- Trade Name
- RESTYLANE REFYNE FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Device Name
- RESTYLANE REFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. FDA UDI
- Model / Reference
- Gel 1 mL Syringe FDA UDI
- Description
- RESTYLANE REFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is indicated for injection into the mid-to-deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds) in patients over the age of 21. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437027710094 FDA UDI
- PMA Number
- P140029 FDA UDI
- FDA Product Code
- LMH FDA UDI
- GMDN Term
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
Yes
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermal tissue reconstructive material, microbe-derived, anaesthetic
Restylane Refyne by Saima Global Farma S.l. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermal tissue reconstructive material, microbe-derived, anaesthetic.
- JUVEDERM ULTRA XC — Allergan · Class III
- Juvederm Volbella — LAMBSMEAD LTD · Class III
- Revanesse Versa+ with Lidocaine 1.0 mL — Prollenium Medical
- Restylane Lyft with Lidocaine — Qmed, Inc. · Class III
- JUVEDERM ULTRA PLUS XC 1ML SAMPLE — Allergan · Class III
- EVOLYSSE FORM — Symatese · Class III
- Restylane-L — Qmed, Inc. · Class III
- Restylane Defyne — Qmed, Inc. · Class III
Cleared under the same submission
P140029 also covers:
- Restylane Contour — Qmed, Inc.
- Restylane Contour — Qmed, Inc.
- Restylane Contour — Qmed, Inc.
- Restylane Contour — Qmed, Inc.
- Restylane Kysse — Qmed, Inc.
- Restylane Kysse — Qmed, Inc.
- Restylane Kysse — Qmed, Inc.
- Restylane Kysse — Qmed, Inc.
- Restylane Kysse — Qmed, Inc.
- Restylane Kysse — Qmed, Inc.
- RESTYLANE DEFYNE — SAIMA GLOBAL FARMA S.L.
- RESTYLANE KYSSE — SAIMA GLOBAL FARMA S.L.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Saima Global Farma S.l.
Sources (1)
- FDA UDI e9c4edce-541b-40f5-9ad4-984ebb133771 35 fields · synced May 30, 2026