Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)— 510(k) K251339

Clearance details

Applicant

Zhengzhou PZ Laser Slim Technology Co., Ltd.

Product code

Code GEX

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2025-04-30

Decision date

2025-07-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

High-Tech Development Zone, CN

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• K261582 — Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)2026-08-28
• K252732 — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)2025-10-23
• K250782 — Fractional CO2 Laser Machine2025-06-12
• K250038 — Muscle Stimulator Device (PZ-100)2025-05-19
• K250041 — Medical Picosecond ND: YAG Laser System (PZ-6)2025-05-14

Death

33

Injury

3,045

Malfunction

12,903

Other

25

Total

16,006

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →