Clearance Summary
neoLaser Laser Surgery Fibers received FDA 510(k) clearance under submission number K250113, sponsored by G.N.S Neolaser , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2025-03-13.
- Submission: K250113
- Applicant / Sponsor: G.N.S Neolaser , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2025-03-13
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.