Identity
- Trade Name
- RESTYLANE LYFT WITH LIDOCAINE FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Device Name
- RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride 0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit. FDA UDI
- Model / Reference
- Gel 1 mL Syringe FDA UDI
- Description
- RESTYLANE LYFT with Lidocaine is a sterile, biodegradable, transparent gel of stabilized hyaluronic acid of non-animal origin with the additon of lidocaine hydrochloride 0.3%. It is indicated in patients over the age of 21 for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds; for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies; and for injection into the subcutaneous plane in the dorsal hand to correct volume deficit. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08437027710087 FDA UDI
- PMA Number
- P040024 FDA UDI
- FDA Product Code
- LMH FDA UDIPKY 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 Lyft With Lidocaine 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
P040024 also covers:
- Restylane — Qmed, Inc.
- Restylane — Qmed, Inc.
- Restylane — Qmed, Inc.
- Restylane — Qmed, Inc.
- Restylane Eyelight — Qmed, Inc.
- Restylane Eyelight — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
- Restylane Lyft with Lidocaine — Qmed, Inc.
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 50d0505b-d5dd-4c14-b6ec-6849c2932cae 35 fields · synced Jun 8, 2026