DemarkQ WOW, DemarkQ POP— 510(k) K203214

Name: FDA 510(k) clearance K203214
Creator: U.S. Food and Drug Administration
Published: 2021-07-22

Substantially Equivalent

Shenzhen Kaiyan Medical CO , Ltd.

FDA 510(k) clearance K203214 for DemarkQ WOW, DemarkQ POP, Substantially Equivalent on 2021-07-22. Applicant: Shenzhen Kaiyan Medical CO , Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Kaiyan Medical CO , Ltd.
Product code: Code OLP
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2020-11-02
Decision date: 2021-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OLP

product code OLP

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.