Oren LED Perioral Light Therapy System— 510(k) K213024

Name: FDA 510(k) clearance K213024
Creator: U.S. Food and Drug Administration
Published: 2021-12-22

Substantially Equivalent

Shenzhen Kaiyan Medical CO , Ltd.

FDA 510(k) clearance K213024 for Oren LED Perioral Light Therapy System, Substantially Equivalent on 2021-12-22. Applicant: Shenzhen Kaiyan Medical CO , Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Kaiyan Medical CO , Ltd.
Product code: Code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2021-09-21
Decision date: 2021-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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K261496 — LED Light Therapy Masks (PE748, PE749, PE756)2026-08-04
K261851 — LED Light Therapy Mask (5 models)2026-08-04
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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.