810nm Diode Laser System— 510(k) K183122

Clearance details

Applicant

Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

Product code

Code GEX

Device class

Class 2

Regulation

21 CFR 878.4810

Advisory panel

General, Plastic Surgery

Date received

2018-11-09

Decision date

2019-08-25

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Shanghai, CN

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• K161356 — Matrix LS-40 CO2 Laser System2016-09-09

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 →