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FDA 510(k)

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine

K-Number: K200983 · 2021-07-14

ApplicantNingbo Hesi Electric Co., Ltd.
Decision Date2021-07-14
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is a medical device manufactured by Ningbo Hesi Electric Co., Ltd.. It received FDA 510(k) clearance on 2021-07-14 under approval number K200983. 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 Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is a medical device that received FDA 510(k) clearance on 2021-07-14. It is manufactured by Ningbo Hesi Electric Co., Ltd.. The 510(k) number is K200983.

When was Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine approved by the FDA?

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine received FDA 510(k) clearance on 2021-07-14, under approval number K200983.

What company makes Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is manufactured by Ningbo Hesi Electric Co., Ltd..

What is the FDA product code for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

The FDA product code for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is OHS.

Related Clinical Trials

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Related PubMed Literature

PMID: 41502788 Translational Evaluation of a Machine Learning-Based Interactive Lab for Aphasia Rehabilitation in Post Stroke Patients. IEEE journal of translational engineering in health and medicine (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

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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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