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FDA 510(k)

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)

K-Number: K253054 · 2025-12-19

ApplicantShenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
Decision Date2025-12-19
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) is a medical device manufactured by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.. It received FDA 510(k) clearance on 2025-12-19 under approval number K253054. 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 (M19, M19-1, M19-2, M19-3, M19-5, M19-6)?

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) is a medical device that received FDA 510(k) clearance on 2025-12-19. It is manufactured by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.. The 510(k) number is K253054.

When was LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) approved by the FDA?

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) received FDA 510(k) clearance on 2025-12-19, under approval number K253054.

What company makes LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)?

LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) is manufactured by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd..

What is the FDA product code for LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)?

The FDA product code for LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) is OHS.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07600957 Polarized Light Therapy for Radiation Dermatitis in Breast Cancer RECRUITING NCT07601841 Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function RECRUITING

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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