Identity
- Trade Name
- RFB, ASSY, FINAL TEMPSURE SYSTEM FDA UDI
- Generic Name
- Electrosurgical system FDA UDI
- Device Name
- RFB, ASSY, FINAL TEMPSURE SYSTEM FDA UDI
- Model / Reference
- R100-7027-010 FDA UDI
- Description
- RFB, ASSY, FINAL TEMPSURE SYSTEM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494108267 FDA UDI
- 510(k) Number
- K171262 FDA UDI
- FDA Product Code
- GEI FDA UDIPBX FDA UDI
- GMDN Term
- Electrosurgical system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Electrosurgical system
Rfb, Assy, Final Tempsure System by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171262 also covers:
- 10mm Portrait Handpiece — Cynosure, LLC
- 15mm Portrait Handpiece — Cynosure, LLC
- 20mm Portrait Handpiece — Cynosure, LLC
- 25mm Portrait Handpiece — Cynosure, LLC
- 30mm Portrait Handpiece — Cynosure, LLC
- ASSY, 25MM Massage Head, TempSure — Cynosure, LLC
- ASSY, 30MM Massage Head, TempSure — Cynosure, LLC
- ASSY, Body Accessory Kit, TempSure — Cynosure, LLC
- ASSY, Face Accessory Kit, TempSure — Cynosure, LLC
- ASSY, Handpiece Kit, TempSure Vitalia — Cynosure, LLC
- ASSY, Probe Kit, 5 PK, TempSure Vitalia — Cynosure, LLC
- ASSY, Probe, Single, TempSure Vitalia — Cynosure, LLC
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
- Cynosure, LLC
Sources (1)
- FDA UDI 1e53afd7-4101-44f4-881e-19a88a7cec78 34 fields · synced Jun 8, 2026