REXLON, REXSIL— 510(k) K161633

Name: FDA 510(k) clearance K161633
Creator: U.S. Food and Drug Administration
Published: 2017-03-02

Substantially Equivalent

Sm Eng Co., Ltd.

FDA 510(k) clearance K161633 for REXLON, REXSIL, Substantially Equivalent on 2017-03-02. Applicant: Sm Eng Co., Ltd.. Device class: 2.

Clearance details

Applicant: Sm Eng Co., Ltd.
Product code: Code GAR
Device class: Class 2
Regulation: 21 CFR 878.5020
Advisory panel: General, Plastic Surgery
Date received: 2016-06-13
Decision date: 2017-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sasang-Gu, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code GAR

product code GAR

Injury: 422
Malfunction: 3,386
Other: 4
Total: 3,812

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.