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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 the device name listed in this FDA 510(k) record. The listed applicant is Hunan Guangye Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-07-19 under 510(k) 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. The listed applicant is Hunan Guangye Biotechnology Co., Ltd.. The 510(k) number is K221151.

When did Beauty LED Mask, Model: KFB265 receive FDA 510(k) clearance?

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

Who is the listed applicant for Beauty LED Mask, Model: KFB265?

The FDA 510(k) record lists Hunan Guangye Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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 records listing Hunan Guangye Biotechnology Co., Ltd. as applicant

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

Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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