GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A— 510(k) K171707

Substantially Equivalent

Gowoonsesang Cosmetics Co., Ltd.

FDA 510(k) clearance K171707 for GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A, Substantially Equivalent on 2017-08-08. Applicant: Gowoonsesang Cosmetics Co., Ltd..

Clearance details

Applicant: Gowoonsesang Cosmetics Co., Ltd.
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2017-06-08
Decision date: 2017-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.