510(k) clearance
Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
- 510(k) number
- K261817
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Decision date
- Sep 17, 2026
- Date received
- Jun 1, 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