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FDA 510(k)

Thermage CPT 系統及附件

K 號:K173759 · 2018-01-08

申請人Solta Medical
決定日期2018-01-08
產品代碼GEI
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

Thermage CPT 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 2018-01-08 under 510(k) number K173759. 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 CPT System and Accessories?

Thermage CPT System and Accessories is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is Solta Medical. The 510(k) number is K173759.

When did Thermage CPT System and Accessories receive FDA 510(k) clearance?

Thermage CPT System and Accessories received FDA 510(k) clearance on 2018-01-08, under 510(k) number K173759.

Who is the listed applicant for Thermage CPT 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 CPT System and Accessories?

The FDA product code for Thermage CPT System and Accessories is GEI.

相關臨床試驗

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其他以 Solta Medical 為申請人之記錄

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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。

官方來源

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