Device details
FDA 510(k) registration fields
- K number
- K250113
- Device name
- neoLaser Laser Surgery Fibers
- Company
- G.N.S Neolaser , Ltd.
- Country / region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-01-16
- Decision date
- 2025-03-13
- Submission type
- Traditional
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Surgical cuttingVascular treatmentOtherSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
