Diode Laser 808nm— 510(k) K192516

Name: FDA 510(k) clearance K192516
Creator: U.S. Food and Drug Administration
Published: 2019-12-10

Substantially Equivalent

Beijing Superlaser Technology Co., Ltd.

FDA 510(k) clearance K192516 for Diode Laser 808nm, Substantially Equivalent on 2019-12-10. Applicant: Beijing Superlaser Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Beijing Superlaser Technology Co., Ltd.
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2019-09-13
Decision date: 2019-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xihongmen Town, Daxing District, Beijing, CN

Download summary PDF View on FDA.gov ↗

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K251457 — Diode laser therapy device (VADER)2025-09-03
K200042 — CO2 Laser System2020-06-09
K193464 — ND:YAG Laser2020-04-13
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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.