LightWalker Laser System Family
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K193661 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 LightWalker Laser System Family is a laser device (GEX product code) designed for soft tissue and hard tissue dental procedures. It delivers precise laser energy for applications such as gingival contouring, periodontal therapy, cavity preparation, and tooth whitening, leveraging multiple wavelengths and pulse modalities for versatility in clinical settings.
This system is supplied as a reusable medical device, intended for use in dental offices and clinics. It operates under FDA clearance (K193661, 510K, SESE decision) and is manufactured by Fotona D.O.O. in Ljubljana, Slovenia. The device requires proper training for operation and must comply with regulatory standards for laser safety and sterility protocols in dental environments.
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. Sources consulted: LightWalker® II - Fotona, Fotona LightWalker® AT-S - Home | Fotona, Grow Your Practice with FOTONA® Lasers | FOTONA®
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K193661 | Class II | Active |
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Manufacturer
- Manufacturer
- Fotona D.O.O.
Sources (1)
- FDA 510(k) K193661 24 fields · synced Sep 20, 2026