FDA 510(k)

Erchonia CLX（型號 # CFL）

K 號：K252574 · 2025-12-15

決定日期2025-12-15

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

Erchonia CLX (Model # CFL) is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K252574. 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 Erchonia CLX (Model # CFL)?

Erchonia CLX (Model # CFL) is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Erchonia Corporation. The 510(k) number is K252574.

When did Erchonia CLX (Model # CFL) receive FDA 510(k) clearance?

Erchonia CLX (Model # CFL) received FDA 510(k) clearance on 2025-12-15, under 510(k) number K252574.

Who is the listed applicant for Erchonia CLX (Model # CFL)?

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

What is the FDA product code for Erchonia CLX (Model # CFL)?

The FDA product code for Erchonia CLX (Model # CFL) is OLI.

其他以 Erchonia Corporation 為申請人之記錄

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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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