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FDA 510(k)

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)

K-Number: K252983 · 2025-12-17

ApplicantShenzhen Goodwind Technology Development Co., Ltd.
Decision Date2025-12-17
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) is a medical device manufactured by Shenzhen Goodwind Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2025-12-17 under approval number K252983. 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 Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)?

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) is a medical device that received FDA 510(k) clearance on 2025-12-17. It is manufactured by Shenzhen Goodwind Technology Development Co., Ltd.. The 510(k) number is K252983.

When was Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) approved by the FDA?

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) received FDA 510(k) clearance on 2025-12-17, under approval number K252983.

What company makes Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)?

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) is manufactured by Shenzhen Goodwind Technology Development Co., Ltd..

What is the FDA product code for Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)?

The FDA product code for Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) 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 Shenzhen Goodwind Technology Development Co., Ltd.

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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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