AviClear Laser System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Cutera, Inc.
Identifiers
- 510(k) Number
- K251149 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AviClear Laser System is a laser device used for aesthetic treatments. It is designed to provide laser therapy for skin conditions.
The system is supplied by Cutera, Inc. and is authorized under FDA 510K, MDD, and MDR regulations. It is intended for use in general and plastic surgery settings.
Frequently asked questions
What is the AviClear Laser System used for?
The AviClear Laser System is a laser device designed for aesthetic treatments, specifically providing laser therapy for skin conditions in general and plastic surgery settings.
How is the AviClear Laser System supplied?
The system is supplied by Cutera, Inc., a manufacturer based in Brisbane, CA, with the device being distributed through their established distribution channels.
What regulatory authorizations does the AviClear Laser System have?
The AviClear Laser System is authorized under FDA 510K, MDD, and MDR regulations, indicating it meets specific regulatory requirements for safety and performance.
In what settings is the AviClear Laser System intended to be used?
The system is intended for use in general and plastic surgery settings, where it can be applied for aesthetic treatments of skin conditions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251149 | Class II | Active |
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Manufacturer
- Manufacturer
- Cutera, Inc.
Sources (2)
- FDA 510(k) K251149 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026