510(k) clearance
1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)
- 510(k) number
- K261589
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decision date
- Sep 2, 2026
- Date received
- May 13, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GEX
- Device type
- Powered Laser Surgical Instrument
- Device class
- Class II
- Regulation
- 21 CFR 878.4810
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Zhengzhou, CN