Diode Laser System GP900A8, Diode Laser System GP900Q8— 510(k) K213225

Name: FDA 510(k) clearance K213225
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Substantially Equivalent

Shenzhen Gsd Tech Co., Ltd.

FDA 510(k) clearance K213225 for Diode Laser System GP900A8, Diode Laser System GP900Q8, Substantially Equivalent on 2021-12-22. Applicant: Shenzhen Gsd Tech Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Gsd Tech Co., Ltd.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-09-29
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

view all

K261562 — Diode Laser Therapy System2026-09-10
K262426 — Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)2026-09-10
K261589 — 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)2026-09-02
K262269 — CO2 Laser System (MBT- CO2 Laser)2026-09-01
K261821 — 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)2026-08-27

More clearances from Shenzhen Gsd Tech Co., Ltd.

view all

K230060 — Light Based Hair Removal Device GP5922023-03-03
K202827 — 308nm Excimer UV-light Skin Therapy System2020-12-15
K191518 — CO2 Laser System2019-09-12
K180383 — Light based hair removal device2018-05-11
K142186 — DIODE LASER HAIR REMOVAL SYSTEM2015-04-17

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, 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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.