K242202
- 510(k) number
- K242202
- Device name
- LightWalker Laser System Family
- Applicant
- Fotona D.O.O. SI
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-08-23
- Date received
- 2024-07-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.9 MB · U.S. public domain
Also available from FDA: K242202.pdf
Official FDA record: K242202
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.