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FDA 510(k)

微電流臉部冷熱服務（型號：TPML-100）

K 號：K213039 · 2022-05-25

申請人Li-Tek Electronics Technology C0., Ltd.
決定日期2022-05-25
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

Micro-current facial cold and hot service (model: TPML-100) is the device name listed in this FDA 510(k) record. The listed applicant is Li-Tek Electronics Technology C0., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K213039. 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 Micro-current facial cold and hot service (model: TPML-100)?

Micro-current facial cold and hot service (model: TPML-100) is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Li-Tek Electronics Technology C0., Ltd.. The 510(k) number is K213039.

When did Micro-current facial cold and hot service (model: TPML-100) receive FDA 510(k) clearance?

Micro-current facial cold and hot service (model: TPML-100) received FDA 510(k) clearance on 2022-05-25, under 510(k) number K213039.

Who is the listed applicant for Micro-current facial cold and hot service (model: TPML-100)?

The FDA 510(k) record lists Li-Tek Electronics Technology C0., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Micro-current facial cold and hot service (model: TPML-100)?

The FDA product code for Micro-current facial cold and hot service (model: TPML-100) is OLP.

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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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相關器械（代碼：OLP）

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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