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FDA 510(k)

LED Light Therapy Mask (model: MK66R-B)

K-Number: K221946 · 2022-11-22

ApplicantLight Tree Ventures Europe B.V.
Decision Date2022-11-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Mask (model: MK66R-B) is a medical device manufactured by Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2022-11-22 under approval number K221946. 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 LED Light Therapy Mask (model: MK66R-B)?

LED Light Therapy Mask (model: MK66R-B) is a medical device that received FDA 510(k) clearance on 2022-11-22. It is manufactured by Light Tree Ventures Europe B.V.. The 510(k) number is K221946.

When was LED Light Therapy Mask (model: MK66R-B) approved by the FDA?

LED Light Therapy Mask (model: MK66R-B) received FDA 510(k) clearance on 2022-11-22, under approval number K221946.

What company makes LED Light Therapy Mask (model: MK66R-B)?

LED Light Therapy Mask (model: MK66R-B) is manufactured by Light Tree Ventures Europe B.V..

What is the FDA product code for LED Light Therapy Mask (model: MK66R-B)?

The FDA product code for LED Light Therapy Mask (model: MK66R-B) 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)

Other Devices by Light Tree Ventures Europe B.V.

K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) K221444LED Eye Perfector, model: EY-36A, EY-36B K222205Cold Sore Device (Model: QPZ-01) K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 K223893Infrared Heat (Model: E0221) K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)

View all 13 devices →

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

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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