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FDA 510(k)

Project E Beauty LED Light Therapy Mask (Model: PE730)

K-Number: K214101 · 2022-03-23

ApplicantDuplex International Trading Limited
Decision Date2022-03-23
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Project E Beauty LED Light Therapy Mask (Model: PE730) is a medical device manufactured by Duplex International Trading Limited. It received FDA 510(k) clearance on 2022-03-23 under approval number K214101. 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 Project E Beauty LED Light Therapy Mask (Model: PE730)?

Project E Beauty LED Light Therapy Mask (Model: PE730) is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Duplex International Trading Limited. The 510(k) number is K214101.

When was Project E Beauty LED Light Therapy Mask (Model: PE730) approved by the FDA?

Project E Beauty LED Light Therapy Mask (Model: PE730) received FDA 510(k) clearance on 2022-03-23, under approval number K214101.

What company makes Project E Beauty LED Light Therapy Mask (Model: PE730)?

Project E Beauty LED Light Therapy Mask (Model: PE730) is manufactured by Duplex International Trading Limited.

What is the FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730)?

The FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730) is OHS.

Related Clinical Trials

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Related PubMed Literature

PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

Related Devices (Code: OHS)

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Official Source

View on FDA Database →

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

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