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FDA 510(k)

燙膚燈

K 號:K221523 · 2023-02-15

決定日期2023-02-15
產品代碼LEJ
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

Tanning Lamp is the device name listed in this FDA 510(k) record. The listed applicant is Unilam Co., Ltd.. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K221523. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Tanning Lamp?

Tanning Lamp is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Unilam Co., Ltd.. The 510(k) number is K221523.

When did Tanning Lamp receive FDA 510(k) clearance?

Tanning Lamp received FDA 510(k) clearance on 2023-02-15, under 510(k) number K221523.

Who is the listed applicant for Tanning Lamp?

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

What is the FDA product code for Tanning Lamp?

The FDA product code for Tanning Lamp is LEJ.

相關臨床試驗

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相關器械(代碼:LEJ)

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。

官方來源

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