髮麥斯雷射
K 號：K180885 · 2018-06-20
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器材摘要
HairMax Laser is the device name listed in this FDA 510(k) record. The listed applicant is Lexington International, LLC. It received FDA 510(k) clearance on 2018-06-20 under 510(k) number K180885. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the HairMax Laser?
HairMax Laser is a medical device that received FDA 510(k) clearance on 2018-06-20. The listed applicant is Lexington International, LLC. The 510(k) number is K180885.
When did HairMax Laser receive FDA 510(k) clearance?
HairMax Laser received FDA 510(k) clearance on 2018-06-20, under 510(k) number K180885.
Who is the listed applicant for HairMax Laser?
The FDA 510(k) record lists Lexington International, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HairMax Laser?
The FDA product code for HairMax Laser is OAP.
相關臨床試驗
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相關器械（代碼：OAP）
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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