K252732
- 510(k) number
- K252732
- Device name
- 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-10-23
- Date received
- 2025-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K252732.pdf
Official FDA record: K252732
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.