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FDA 510(k)

LED光疗硅胶面罩（kks-225, kks-280, kks-281）

K号: K254007 · 2026-02-12

申请人SZ KKS Silicone&Electronic Co., Ltd.
决定日期2026-02-12
产品代码OHS
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) is the device name listed in this FDA 510(k) record. The listed applicant is SZ KKS Silicone&Electronic Co., Ltd.. It received FDA 510(k) clearance on 2026-02-12 under 510(k) number K254007. 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 LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)?

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) is a medical device that received FDA 510(k) clearance on 2026-02-12. The listed applicant is SZ KKS Silicone&Electronic Co., Ltd.. The 510(k) number is K254007.

When did LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) receive FDA 510(k) clearance?

LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) received FDA 510(k) clearance on 2026-02-12, under 510(k) number K254007.

Who is the listed applicant for LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)?

The FDA 510(k) record lists SZ KKS Silicone&Electronic Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)?

The FDA product code for LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) is OHS.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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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