SculpSure
K 號：K182741 · 2019-01-03
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器材摘要
SculpSure is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure. It received FDA 510(k) clearance on 2019-01-03 under 510(k) number K182741. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the SculpSure?
SculpSure is a medical device that received FDA 510(k) clearance on 2019-01-03. The listed applicant is Cynosure. The 510(k) number is K182741.
When did SculpSure receive FDA 510(k) clearance?
SculpSure received FDA 510(k) clearance on 2019-01-03, under 510(k) number K182741.
Who is the listed applicant for SculpSure?
The FDA 510(k) record lists Cynosure as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SculpSure?
The FDA product code for SculpSure is PKT.
相關臨床試驗
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相關器械（代碼：PKT）
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
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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