FDA 510(k)

Contour Light (CL-100)

K 號：K243854 · 2026-02-13

決定日期2026-02-13

產品代碼OLI

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

Contour Light (CL-100) is the device name listed in this FDA 510(k) record. The listed applicant is Contour Research, LLC. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K243854. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Contour Light (CL-100)?

Contour Light (CL-100) is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is Contour Research, LLC. The 510(k) number is K243854.

When did Contour Light (CL-100) receive FDA 510(k) clearance?

Contour Light (CL-100) received FDA 510(k) clearance on 2026-02-13, under 510(k) number K243854.

Who is the listed applicant for Contour Light (CL-100)?

The FDA 510(k) record lists Contour Research, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Contour Light (CL-100)?

The FDA product code for Contour Light (CL-100) is OLI.

其他以 Contour Research, LLC 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。

K202955輪廓光CL-100

相關器械（代碼：OLI）

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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