Dermatological diode laser system— 510(k) K212478

Name: FDA 510(k) clearance K212478
Creator: U.S. Food and Drug Administration
Published: 2022-01-14

Substantially Equivalent

Beijing Stelle Laser Technology Co., Ltd.

FDA 510(k) clearance K212478 for Dermatological diode laser system, Substantially Equivalent on 2022-01-14. Applicant: Beijing Stelle Laser Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Stelle Laser Technology Co., Ltd.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-08-09
Decision date: 2022-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beijing, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEX

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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

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.