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FDA 510(k)

Beauty LED Mask, Model: KFB265

K-Number: K221151 · 2022-07-19

ApplicantHunan Guangye Biotechnology Co., Ltd.
Decision Date2022-07-19
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Beauty LED Mask, Model: KFB265 is a medical device manufactured by Hunan Guangye Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-19 under approval number K221151. 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 Beauty LED Mask, Model: KFB265?

Beauty LED Mask, Model: KFB265 is a medical device that received FDA 510(k) clearance on 2022-07-19. It is manufactured by Hunan Guangye Biotechnology Co., Ltd.. The 510(k) number is K221151.

When was Beauty LED Mask, Model: KFB265 approved by the FDA?

Beauty LED Mask, Model: KFB265 received FDA 510(k) clearance on 2022-07-19, under approval number K221151.

What company makes Beauty LED Mask, Model: KFB265?

Beauty LED Mask, Model: KFB265 is manufactured by Hunan Guangye Biotechnology Co., Ltd..

What is the FDA product code for Beauty LED Mask, Model: KFB265?

The FDA product code for Beauty LED Mask, Model: KFB265 is OHS.

Other Devices by Hunan Guangye Biotechnology Co., Ltd.

K222432IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439

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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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