Identity
- Trade Name
- CLEAR+BRILLIANT FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- TIP, CLEAR+BRILLIANT, 12-PACK FDA UDI
- Model / Reference
- CBT-KEY-12 FDA UDI
- Description
- TIP, CLEAR+BRILLIANT, 12-PACK FDA UDI
Identifiers
- Catalog Number
- CBT-KEY-12 FDA UDI
- Primary DI / UDI-DI
- 00816995027331 FDA UDI
- FDA Product Code
- ONG FDA UDI
- GMDN Term
- Dermatological laser beam guiding handpiece 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
Yes
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
Yes
FDA UDI
Category: Dermatological laser beam guiding handpiece
Clear+brilliant by Solta Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological laser beam guiding handpiece.
- GentleYAG 1.5/3MM Delivery System W/DCD — Candela Corporation · Class II
- hydrosun 750 — Hydrosun Medizintechnik GmbH · Class IIa
- GentleYAG 3MM Delivery System W/O DCD — Candela Corporation · Class II
- External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima — Candela Corporation · Class II
- TL 30 — Globalcare Medical Technology Co., Ltd. · Class IIa
- Open — Candela Corporation · Class II
- HydraFacial — Hydrafacial LLC · Class I
- Nubway — Beijing Nubway S&T Co., Ltd. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Solta Medical, Inc.
Sources (1)
- FDA UDI f35f1a79-a9d9-46c6-b08b-9e5a8c21072b 34 fields · synced Jun 8, 2026