Identity
- Trade Name
- 3MM Handpiece Assembly FDA UDI
- Generic Name
- Dermatological laser beam guiding handpiece FDA UDI
- Device Name
- Hand-piece Assembly FDA UDI
- Model / Reference
- 7122-00-1100 FDA UDI
- Description
- Hand-piece Assembly FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817495020457 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
- 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
3MM Handpiece Assembly by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 2MM 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
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
- Candela Corporation
Sources (1)
- FDA UDI 3e641ac9-013b-44dc-aae9-dfe875eb23b3 36 fields · synced Jun 8, 2026