K250656
- 510(k) number
- K250656
- Device name
- Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
- Applicant
- Wuhan Pioon Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-04-04
- Date received
- 2025-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K250656.pdf
Official FDA record: K250656
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.