FDA 510(k)

皮膚針精準系統

K 號：K220506 · 2022-03-07

決定日期2022-03-07

產品代碼QAI

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

SkinPen Precision System is the device name listed in this FDA 510(k) record. The listed applicant is Crown Aesthetics. It received FDA 510(k) clearance on 2022-03-07 under 510(k) number K220506. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SkinPen Precision System?

SkinPen Precision System is a medical device that received FDA 510(k) clearance on 2022-03-07. The listed applicant is Crown Aesthetics. The 510(k) number is K220506.

When did SkinPen Precision System receive FDA 510(k) clearance?

SkinPen Precision System received FDA 510(k) clearance on 2022-03-07, under 510(k) number K220506.

Who is the listed applicant for SkinPen Precision System?

The FDA 510(k) record lists Crown Aesthetics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkinPen Precision System?

The FDA product code for SkinPen Precision System is QAI.

其他以 Crown Aesthetics 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。

K241400皮膚針精準精英系統 K202243皮膚針精準系統

相關器械（代碼：QAI）

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。

K252591自動微針系統 (CODE-X)Woorhi Mechatronics Co., Ltd.K253002皮膚筆SteriLock微系統（MP1209SL）Esthetic Medical, Inc.K252752艾拉可爾系統搭配微孔技術Cytrellis Biosystems, Inc.K253153SER Pen Carain 微系統 (MP1209SP)Su-Ko Technologies, LLC K243800PRO Pen 微針治療系統（6883）Dermalogica, LLC K243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.

官方來源

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