Identity
- Trade Name
- Radiesse (+) Lidocaine FDA UDI
- Generic Name
- Dermal tissue reconstructive material, microbe-derived, anaesthetic FDA UDI
- Device Name
- Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles. FDA UDI
- Model / Reference
- 8063M0K2 FDA UDI
- Description
- Radiesse (+) Lidocaine 1.5cc Injectable Implant is a volumizing filler with integral lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (2) 1.5cc Injectable Implant and (4) 27 gauge thin walled x 0.75" needles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M2138063M0K25 FDA UDI
- PMA Number
- P050052 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
Yes
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
Dimensions & Sizes
- Size
- Total Volume — 3.0 Milliliter FDA UDI
Category: Dermal tissue reconstructive material, microbe-derived, anaesthetic
Radiesse (+) Lidocaine by Merz North America, Inc. — 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 KYSSE — SAIMA GLOBAL FARMA S.L. · Class III
- 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
Cleared under the same submission
P050052 also covers:
- Radiesse (+) Lidocaine 0.8cc Injectable Implant — Merz North America, Inc.
- Radiesse (+) Lidocaine1.5cc Injectable Implant — Merz North America, Inc.
- Radiesse Moderate Fill 0.8cc — Merz North America, Inc.
- Radiesse Volume Advantage — Merz North America, Inc.
- Radiesse Volume Advantage 1.5cc — Merz North America, Inc.
- Radiesse Volume Advantage 1.5cc — Merz North America, Inc.
- Radiesse — UNIVERDERM
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
- Merz North America, Inc.
Sources (1)
- FDA UDI 46c79b41-794c-4da2-aeee-383dd610d4bc 37 fields · synced Jun 9, 2026