K242987
- 510(k) number
- K242987
- Device name
- Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
- Applicant
- Allengers Global Healthcare Private Limited IN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-12-17
- Date received
- 2024-09-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242987.pdf
Official FDA record: K242987
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.