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FDA 510(k)

Shani Darden LED light therapy mask

K-Number: K214103 · 2022-03-22

ApplicantHarpar Grace International
Decision Date2022-03-22
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Shani Darden LED light therapy mask is a medical device manufactured by Harpar Grace International. It received FDA 510(k) clearance on 2022-03-22 under approval number K214103. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shani Darden LED light therapy mask?

Shani Darden LED light therapy mask is a medical device that received FDA 510(k) clearance on 2022-03-22. It is manufactured by Harpar Grace International. The 510(k) number is K214103.

When was Shani Darden LED light therapy mask approved by the FDA?

Shani Darden LED light therapy mask received FDA 510(k) clearance on 2022-03-22, under approval number K214103.

What company makes Shani Darden LED light therapy mask?

Shani Darden LED light therapy mask is manufactured by Harpar Grace International.

What is the FDA product code for Shani Darden LED light therapy mask?

The FDA product code for Shani Darden LED light therapy mask is OLP.

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)

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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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