Device details
FDA 510(k) registration fields
- K number
- K201171
- Device name
- LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable
- Company
- Leoni Fiber Optics, Inc.
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-05-01
- Decision date
- 2021-04-02
- Submission type
- Traditional
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatmentOtherSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
