K233304
- 510(k) number
- K233304
- Device name
- Omnimax S3, Omnimax S4
- Applicant
- Sharplight Technologies, Ltd. IL
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2023-12-22
- Date received
- 2023-09-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233304.pdf
Official FDA record: K233304
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.