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FDA 510(k)

LED光療面膜（E43、E32、E49B、E49C、E100B、E100C、E103B、E104B、E106A、E108A）

K 號：K243555 · 2025-02-05

申請人Shenzhen Eyco Technology Co., Ltd.
決定日期2025-02-05
產品代碼OLP
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 mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Eyco Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K243555. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)?

LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Shenzhen Eyco Technology Co., Ltd.. The 510(k) number is K243555.

When did LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) receive FDA 510(k) clearance?

LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) received FDA 510(k) clearance on 2025-02-05, under 510(k) number K243555.

Who is the listed applicant for LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)?

The FDA 510(k) record lists Shenzhen Eyco Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A)?

The FDA product code for LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) is OLP.

相關臨床試驗

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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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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