Identity
- Trade Name
- truSculpt FDA UDI
- Generic Name
- Radio-frequency skin/body contouring system FDA UDI
- Device Name
- truSculpt RF Device FDA UDI
- Model / Reference
- truSculpt FDA UDI
- Description
- truSculpt RF Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00816722021403 FDA UDI
- FDA Product Code
- PBX FDA UDINUV FDA UDIISA FDA UDI
- GMDN Term
- Radio-frequency skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 FDA UDI890.5660 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
truSculpt by Cutera, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Cutera, Inc.
Sources (1)
- FDA UDI 16be0c7a-0146-452a-9f78-e0521d9e9afe 35 fields · synced Jun 8, 2026