Identity
- Trade Name
- RESTYLANE DEFYNE FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Device Name
- RESTYLANE DEFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is is indicated in patients over the age of 21 for injection into the mid-to-deep dermis for correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) and for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion. FDA UDI
- Model / Reference
- Gel 1 mL Syringe FDA UDI
- Description
- RESTYLANE DEFYNE is a sterile, biodegradable, transparent gel of non-animal cross-linked hyaluronic acid with the addition of lidocaine hydrochloride 0.3%. It is is indicated in patients over the age of 21 for injection into the mid-to-deep dermis for correction of moderate to severe, deep facial wrinkles and folds (such as nasolabial folds) and for augmentation of the chin region to improve the chin profile in patients with mild to moderate chin retrusion. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437027710063 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 Defyne 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 KYSSE — SAIMA GLOBAL FARMA S.L.
- RESTYLANE REFYNE — 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 552eaa0b-dfc2-4f14-9f40-6326a0eee5c2 35 fields · synced Jun 1, 2026