路達尼克斯 精英
K 號：K253484 · 2026-06-29
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決定日期2026-06-29
產品代碼GEI
諮詢委員會SU
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決定相當於
器材摘要
LUTRONIC GENIUS is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure Lutronic Technology Corporation. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K253484. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the LUTRONIC GENIUS?
LUTRONIC GENIUS is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Cynosure Lutronic Technology Corporation. The 510(k) number is K253484.
When did LUTRONIC GENIUS receive FDA 510(k) clearance?
LUTRONIC GENIUS received FDA 510(k) clearance on 2026-06-29, under 510(k) number K253484.
Who is the listed applicant for LUTRONIC GENIUS?
The FDA 510(k) record lists Cynosure Lutronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LUTRONIC GENIUS?
The FDA product code for LUTRONIC GENIUS is GEI.
相關臨床試驗
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。
相關器械（代碼：GEI）
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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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