Identity
- Trade Name
- Refurbished GentleMax Pro Plus FDA UDI
- Generic Name
- Dermatological solid-state laser system FDA UDI
- Device Name
- Refurbished GentleMax Pro Plus FDA UDI
- Model / Reference
- 9914-57-9036 FDA UDI
- Description
- Refurbished GentleMax Pro Plus FDA UDI
Identifiers
- Catalog Number
- 9914-57-9036 FDA UDI
- Primary DI / UDI-DI
- 00817495024110 FDA UDI
- 510(k) Number
- K201111 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological solid-state laser system 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 solid-state laser system
Refurbished GentleMax Pro Plus by Candela Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dermatological solid-state laser system.
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- CLARITY II — Lutronic Corporation · Class II
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 4504dcbe-8d4e-4457-bbf5-fa9581f59327 35 fields · synced Jun 8, 2026