Identity
- Trade Name
- ACC HAND PIECE, LARGE SPOT, GMPP FDA UDI
- Generic Name
- Dermatological laser beam producing handpiece FDA UDI
- Model / Reference
- 7123-CE-0628 FDA UDI
Identifiers
- Catalog Number
- 7123-CE-0628 FDA UDI
- Primary DI / UDI-DI
- 00817495023137 FDA UDI
- 510(k) Number
- K201111 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological laser beam producing 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Acc Hand Piece, Large Spot, Gmpp by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K201111 also covers:
- ASSY, ACC HAND PIECE, LARGE SPOT, GMPP — Candela Corporation
- ASSY, DCD HAND PIECE, LARGE SPOT, GMPP — Candela Corporation
- FIBER, LARGE SPOT, GC, GMPP — Candela Corporation
- FIBER, STANDARD, HC, GMPP — Candela Corporation
- FIBER, STANDARD, HC, GMPP — Candela Corporation
- FIBER, STANDARD, HC, GMPP — Candela Corporation
- GMAX Pro Plus Laser System — Candela Corporation
- GMPP ACC HP AIR CLIP Kit, w/o Fiber Assembly — Candela Corporation
- GMPP ACC Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly — Candela Corporation
- GMPP DCD Large Spot Option Kit, w/HP, w/SAs, w/Fiber Assembly — Candela Corporation
- GMPP DCD Small Spot Option Kit, w/Fiber Assembly — Candela Corporation
- GentleMAX PRO PLUS Laser 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 f2365b98-9563-4301-945c-7e6c19c4c52a 35 fields · synced Jun 8, 2026