BodySculp
K 號：K212331 · 2021-11-09
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器材摘要
BodySculp is the device name listed in this FDA 510(k) record. The listed applicant is Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K212331. 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 BodySculp?
BodySculp is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Rohrer Aesthetics, LLC. The 510(k) number is K212331.
When did BodySculp receive FDA 510(k) clearance?
BodySculp received FDA 510(k) clearance on 2021-11-09, under 510(k) number K212331.
Who is the listed applicant for BodySculp?
The FDA 510(k) record lists Rohrer Aesthetics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BodySculp?
The FDA product code for BodySculp is PKT.
相關臨床試驗
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其他以 Rohrer Aesthetics, LLC 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：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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