FDA 510(k)

Focal One®

K 號：K251910 · 2025-11-19

決定日期2025-11-19

產品代碼PLP

諮詢委員會GU

決定相當於

器材摘要

Focal One® is the device name listed in this FDA 510(k) record. The listed applicant is Edap Technomed, Inc.. It received FDA 510(k) clearance on 2025-11-19 under 510(k) number K251910. The device is classified under product code PLP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Focal One®?

Focal One® is a medical device that received FDA 510(k) clearance on 2025-11-19. The listed applicant is Edap Technomed, Inc.. The 510(k) number is K251910.

When did Focal One® receive FDA 510(k) clearance?

Focal One® received FDA 510(k) clearance on 2025-11-19, under 510(k) number K251910.

Who is the listed applicant for Focal One®?

The FDA 510(k) record lists Edap Technomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Focal One®?

The FDA product code for Focal One® is PLP.

其他以 Edap Technomed, Inc. 為申請人之記錄

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K172721FOCAL ONE K172285Ablatherm 融合

相關器械（代碼：PLP）

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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