Identity
- Trade Name
- Fraxel FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- Fraxel re:pair barrel without FDA UDI
- Model / Reference
- MC-RE:PAIR-NO-SPATULA FDA UDI
- Description
- Fraxel re:pair barrel without FDA UDI
Identifiers
- Catalog Number
- MC-RE:PAIR-NO-SPATULA FDA UDI
- Primary DI / UDI-DI
- 00816995020417 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dermatological carbon dioxide laser system
Fraxel by Solta Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Solta Medical, Inc.
Sources (1)
- FDA UDI d55cb739-ad6c-4f7a-9ffc-6854ff820206 34 fields · synced Jun 6, 2026