K243147
- 510(k) number
- K243147
- Device name
- LGO-Surgical Laser Fibers
- Applicant
- Light Guide Optics International , Ltd. LV
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-12-21
- Date received
- 2024-09-30
- 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: K243147.pdf
Official FDA record: K243147
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.