K241498
- 510(k) number
- K241498
- Device name
- Diode laser Treatment System (K18)
- Applicant
- Hebei Keylaser Sci-Tech Co.,Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-11-18
- Date received
- 2024-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K241498.pdf
Official FDA record: K241498
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.