1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)— 510(k) K261589
Substantially EquivalentZhengzhou PZ Laser Slim Technology Co., Ltd.
FDA 510(k) clearance K261589 for 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02), Substantially Equivalent on 2026-09-02. Applicant: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Device class: 2.
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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Zhengzhou, CN
Recent devices under product code GEX
view allMore clearances from Zhengzhou PZ Laser Slim Technology Co., Ltd.
view all- K261582 — Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
- K252732 — 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)
- K251339 — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
- K250782 — Fractional CO2 Laser Machine
- K250038 — Muscle Stimulator Device (PZ-100)
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.