K250113
- 510(k) number
- K250113
- Device name
- neoLaser Laser Surgery Fibers
- Applicant
- G.N.S Neolaser , Ltd. IL
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-03-13
- Date received
- 2025-01-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250113.pdf
Official FDA record: K250113
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.