Opera Lebody (Gold), Opera Lebody (Zafiro)— 510(k) K201107

Name: FDA 510(k) clearance K201107
Creator: U.S. Food and Drug Administration
Published: 2020-06-22

Substantially Equivalent

Gtg Wellness Co., Ltd.

FDA 510(k) clearance K201107 for Opera Lebody (Gold), Opera Lebody (Zafiro), Substantially Equivalent on 2020-06-22. Applicant: Gtg Wellness Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gtg Wellness Co., Ltd.
Product code: Code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2020-04-24
Decision date: 2020-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yongin-Si, KR

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

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.