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.
Summary
1927nm Thulium Laser System, models PZ-DJG85-01 and PZ-DJG85-02, is from Zhengzhou PZ Laser Slim Technology Co., Ltd., filed under product code GEX (Powered Laser Surgical Instrument). The record doesn't say how the two models differ.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
The company filed from Zhengzhou, China. The decision came 112 calendar days after receipt (May 13 to September 2, 2026).
Clearance details
- Applicant
- Zhengzhou PZ Laser Slim Technology Co., Ltd.
- Product code
- Product 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- K261817 — Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)
- K261582 — Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)
- K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)
- 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)
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.