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FDA 510(k)

LED光療矽膠臉部護膚罩（kks-225、kks-280、kks-281）

K 號：K254007 · 2026-02-12

申請人SZ KKS Silicone&Electronic Co., Ltd.
決定日期2026-02-12
產品代碼OHS
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

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相關器械（代碼：OHS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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