Omega VL— 510(k) K162366
Substantially EquivalentOv World Co., Ltd.
FDA 510(k) clearance K162366 for Omega VL, Substantially Equivalent on 2018-03-02. Applicant: Ov World Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Ov World Co., Ltd.
- Product code
- Code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
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Adverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
Source: openFDA MAUDE database, through . 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.