K241791
- 510(k) number
- K241791
- Device name
- Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
- Applicant
- Gigaalaser Company , Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-03-19
- Date received
- 2024-06-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.6 MB · U.S. public domain
Also available from FDA: K241791.pdf
Official FDA record: K241791
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.