K240644
- 510(k) number
- K240644
- Device name
- Medical Diode Laser (S1Pro)
- Applicant
- Wuhan Pioon Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-06-10
- Date received
- 2024-03-07
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K240644.pdf
Official FDA record: K240644
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.