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FDA 510(k)

皮膚筆SteriLock微系統

K 號:K200044 · 2020-04-10

決定日期2020-04-10
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

SkinStylus SteriLock MicroSystem is the device name listed in this FDA 510(k) record. The listed applicant is Esthetic Education, LLC. It received FDA 510(k) clearance on 2020-04-10 under 510(k) number K200044. 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 SkinStylus SteriLock MicroSystem?

SkinStylus SteriLock MicroSystem is a medical device that received FDA 510(k) clearance on 2020-04-10. The listed applicant is Esthetic Education, LLC. The 510(k) number is K200044.

When did SkinStylus SteriLock MicroSystem receive FDA 510(k) clearance?

SkinStylus SteriLock MicroSystem received FDA 510(k) clearance on 2020-04-10, under 510(k) number K200044.

Who is the listed applicant for SkinStylus SteriLock MicroSystem?

The FDA 510(k) record lists Esthetic Education, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SkinStylus SteriLock MicroSystem?

The FDA product code for SkinStylus SteriLock MicroSystem is QAI.

相關臨床試驗

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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。

官方來源

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