FDA 510(k)

CurrentBody Skin™ LED 光疗面膜系列 2 (MK-90H)

K号: K250966 · 2025-06-25

申请人Shenzhen Kaiyan Medical Equipment Co., Ltd.

决定日期2025-06-25

产品代码OHS

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决定实质等同

器械摘要

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-06-25 under 510(k) number K250966. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)?

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250966.

When did CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) receive FDA 510(k) clearance?

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250966.

Who is the listed applicant for CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)?

FDA 510(k)记录将深圳凯研医疗设备有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)?

The FDA product code for CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) is OHS.

列明Shenzhen Kaiyan Medical Equipment Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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查看所有 24 个设备 →

相关器械（代码：OHS）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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