K240520
- 510(k) number
- K240520
- Device name
- Diode Laser Hair Removal System (SH-VD910)
- Applicant
- Beijing Sea Heart International Science and Technologyco.Ltd CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-05-20
- Date received
- 2024-02-23
- 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: K240520.pdf
Official FDA record: K240520
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.