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FDA 510(k)

Skin Care Beauty Mask (Model: MJ-06)

K-Number: K220168 · 2022-05-17

ApplicantShenzhen Kaiyan Medical CO , Ltd.
Decision Date2022-05-17
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Skin Care Beauty Mask (Model: MJ-06) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. It received FDA 510(k) clearance on 2022-05-17 under 510(k) number K220168. 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 Skin Care Beauty Mask (Model: MJ-06)?

Skin Care Beauty Mask (Model: MJ-06) is a medical device that received FDA 510(k) clearance on 2022-05-17. The listed applicant is Shenzhen Kaiyan Medical CO , Ltd.. The 510(k) number is K220168.

When did Skin Care Beauty Mask (Model: MJ-06) receive FDA 510(k) clearance?

Skin Care Beauty Mask (Model: MJ-06) received FDA 510(k) clearance on 2022-05-17, under 510(k) number K220168.

Who is the listed applicant for Skin Care Beauty Mask (Model: MJ-06)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Skin Care Beauty Mask (Model: MJ-06)?

The FDA product code for Skin Care Beauty Mask (Model: MJ-06) is OHS.

Other records listing Shenzhen Kaiyan Medical CO , Ltd. as applicant

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.

K213024Oren LED Perioral Light Therapy SystemK203214DemarkQ WOW, DemarkQ POPK203271Aduro light therapy HandheldK202390Aduro Light Beauty Mask

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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