1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)— 510(k) K261821
Substantially EquivalentZhengzhou PZ Laser Slim Technology Co., Ltd.
FDA 510(k) clearance K261821 for 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02), Substantially Equivalent on 2026-08-27. 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 all- K261964 — ECHOLASER X4
- K262070 — Diode Laser Therapy Systems (DL612A)
- K261841 — Q Switched Nd:YAG Laser machine (QLQW-01)
- K261221 — SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
- K261738 — Medical Thulium Fiber Laser Systems (UroFiber 150Q)
More 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.