K250041
- 510(k) number
- K250041
- Device name
- Medical Picosecond ND: YAG Laser System (PZ-6)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-05-14
- Date received
- 2025-01-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250041.pdf
Official FDA record: K250041
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.