K242349
- 510(k) number
- K242349
- Device name
- FoLix
- Applicant
- Lumenis Be, Ltd. IL
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-09-09
- Date received
- 2024-08-08
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242349.pdf
Official FDA record: K242349
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.