Identity
- Trade Name
- Alex TriVantage 2MM Handpiece Assembly FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- Handpiece Assembly FDA UDI
- Model / Reference
- 7122-00-1053 FDA UDI
- Description
- Handpiece Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495022185 FDA UDI
- 510(k) Number
- K081324 FDA UDI
- FDA Product Code
- GEX 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
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: Dermatological laser beam guiding handpiece
Alex TriVantage 2MM Handpiece Assembly by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K081324 also covers:
- ALEX TriVantage — Candela Corporation
- Alex TriVantage — Candela Corporation
- Alex TriVantage — Candela Corporation
- Alex TriVantage — Candela Corporation
- Alex TriVantage 1064 Handpiece Assembly — Candela Corporation
- Alex TriVantage 1064 Handpiece Assembly — Candela Corporation
- Alex TriVantage 3MM Handpiece Assembly — Candela Corporation
- Alex TriVantage 4MM Handpiece Assembly — Candela Corporation
- Alex TriVantage 532 Handpiece Assembly — Candela Corporation
- Alex TriVantage 532 PT Handpiece Assembly — Candela Corporation
- Alex TriVantage Delivery System — Candela Corporation
- AlexLAZR — Candela Corporation
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
- Candela Corporation
Sources (1)
- FDA UDI 7d5de5c1-32d6-4c8c-aeed-0fc8425569e5 34 fields · synced Jun 8, 2026