FDA 510(k)

Enlight 2100 (TPL-E2103-0)

K 號：K250464 · 2025-09-10

決定日期2025-09-10

產品代碼QEB

諮詢委員會AN

決定相當於

器材摘要

Enlight 2100 (TPL-E2103-0) is the device name listed in this FDA 510(k) record. The listed applicant is Timpel S.A.. It received FDA 510(k) clearance on 2025-09-10 under 510(k) number K250464. The device is classified under product code QEB. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Enlight 2100 (TPL-E2103-0)?

Enlight 2100 (TPL-E2103-0) is a medical device that received FDA 510(k) clearance on 2025-09-10. The listed applicant is Timpel S.A.. The 510(k) number is K250464.

When did Enlight 2100 (TPL-E2103-0) receive FDA 510(k) clearance?

Enlight 2100 (TPL-E2103-0) received FDA 510(k) clearance on 2025-09-10, under 510(k) number K250464.

Who is the listed applicant for Enlight 2100 (TPL-E2103-0)?

The FDA 510(k) record lists Timpel S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enlight 2100 (TPL-E2103-0)?

The FDA product code for Enlight 2100 (TPL-E2103-0) is QEB.

其他以 Timpel S.A. 為申請人之記錄

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。

K222897啟明2100 K211135啟明2100

相關器械（代碼：QEB）

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。

K243765LuMon™ 系統Sentec AG K222466AirTomBilab K222897啟明2100Timpel S.A.K211135啟明2100Timpel S.A.

官方來源

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