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FDA 510(k)

Oren LED Perioral Light Therapy System

K-Number: K213024 · 2021-12-22

ApplicantShenzhen Kaiyan Medical CO , Ltd.
Decision Date2021-12-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Oren LED Perioral Light Therapy System is a medical device manufactured by Shenzhen Kaiyan Medical CO , Ltd.. It received FDA 510(k) clearance on 2021-12-22 under approval number K213024. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Oren LED Perioral Light Therapy System?

Oren LED Perioral Light Therapy System is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Shenzhen Kaiyan Medical CO , Ltd.. The 510(k) number is K213024.

When was Oren LED Perioral Light Therapy System approved by the FDA?

Oren LED Perioral Light Therapy System received FDA 510(k) clearance on 2021-12-22, under approval number K213024.

What company makes Oren LED Perioral Light Therapy System?

Oren LED Perioral Light Therapy System is manufactured by Shenzhen Kaiyan Medical CO , Ltd..

What is the FDA product code for Oren LED Perioral Light Therapy System?

The FDA product code for Oren LED Perioral Light Therapy System is OHS.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018) PMID: 29060903 Development of evaluation methods for the approval and review of Intense pulsed light (IPL). Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2017)

Other Devices by Shenzhen Kaiyan Medical CO , Ltd.

K203214DemarkQ WOW, DemarkQ POP K203271Aduro light therapy Handheld K202390Aduro Light Beauty Mask K220168Skin Care Beauty Mask (Model: MJ-06)

Related Devices (Code: OHS)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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