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FDA 510(k)

LED Light Therapy Mask (Models: T2, RLD10)

K-Number: K254079 · 2026-03-16

ApplicantShenzhen Desida Technology Co., Ltd.
Decision Date2026-03-16
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Mask (Models: T2, RLD10) is a medical device manufactured by Shenzhen Desida Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under approval number K254079. 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 (Models: T2, RLD10)?

LED Light Therapy Mask (Models: T2, RLD10) is a medical device that received FDA 510(k) clearance on 2026-03-16. It is manufactured by Shenzhen Desida Technology Co., Ltd.. The 510(k) number is K254079.

When was LED Light Therapy Mask (Models: T2, RLD10) approved by the FDA?

LED Light Therapy Mask (Models: T2, RLD10) received FDA 510(k) clearance on 2026-03-16, under approval number K254079.

What company makes LED Light Therapy Mask (Models: T2, RLD10)?

LED Light Therapy Mask (Models: T2, RLD10) is manufactured by Shenzhen Desida Technology Co., Ltd..

What is the FDA product code for LED Light Therapy Mask (Models: T2, RLD10)?

The FDA product code for LED Light Therapy Mask (Models: T2, RLD10) is OHS.

Related Clinical Trials

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Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

Other Devices by Shenzhen Desida Technology Co., Ltd.

K221643Hair Removal Device (Model: IPL-D26, IPL-D19) K221635IPL sapphire ice cooling hair remove device K233901Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) K251450Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator (BN007); Baby Nasal Aspirator (BN008); Baby Nasal Aspirator (BN009) K244033Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)

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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