Thermage FLX 系統及配件
K 號：K170758 · 2017-09-22
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器材摘要
Thermage FLX System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K170758. 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 Thermage FLX System and Accessories?
Thermage FLX System and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Solta Medical. The 510(k) number is K170758.
When did Thermage FLX System and Accessories receive FDA 510(k) clearance?
Thermage FLX System and Accessories received FDA 510(k) clearance on 2017-09-22, under 510(k) number K170758.
Who is the listed applicant for Thermage FLX System and Accessories?
The FDA 510(k) record lists Solta Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Thermage FLX System and Accessories?
The FDA product code for Thermage FLX System and Accessories 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。
其他以 Solta Medical 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。
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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