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FDA 510(k)

LED light therapy mask (FM-01, FM-02, FM-03)

K-Number: K223544 · 2023-02-23

ApplicantGuangdong Newdermo Biotech Co., Ltd.
Decision Date2023-02-23
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LED light therapy mask (FM-01, FM-02, FM-03) is a medical device manufactured by Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2023-02-23 under approval number K223544. 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 (FM-01, FM-02, FM-03)?

LED light therapy mask (FM-01, FM-02, FM-03) is a medical device that received FDA 510(k) clearance on 2023-02-23. It is manufactured by Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K223544.

When was LED light therapy mask (FM-01, FM-02, FM-03) approved by the FDA?

LED light therapy mask (FM-01, FM-02, FM-03) received FDA 510(k) clearance on 2023-02-23, under approval number K223544.

What company makes LED light therapy mask (FM-01, FM-02, FM-03)?

LED light therapy mask (FM-01, FM-02, FM-03) is manufactured by Guangdong Newdermo Biotech Co., Ltd..

What is the FDA product code for LED light therapy mask (FM-01, FM-02, FM-03)?

The FDA product code for LED light therapy mask (FM-01, FM-02, FM-03) 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)

Other Devices by Guangdong Newdermo Biotech Co., Ltd.

K260202LED Light Therapy Masks (LumiLips FAC07NA)

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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