FDA 510(k)

Pulsaderm ACE-全藍

K 號：K162371 · 2016-12-15

決定日期2016-12-15

產品代碼OLP

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

Pulsaderm ACE-All Blue is the device name listed in this FDA 510(k) record. The listed applicant is Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K162371. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pulsaderm ACE-All Blue?

Pulsaderm ACE-All Blue is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Nutra Luxe MD, LLC. The 510(k) number is K162371.

When did Pulsaderm ACE-All Blue receive FDA 510(k) clearance?

Pulsaderm ACE-All Blue received FDA 510(k) clearance on 2016-12-15, under 510(k) number K162371.

Who is the listed applicant for Pulsaderm ACE-All Blue?

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

What is the FDA product code for Pulsaderm ACE-All Blue?

The FDA product code for Pulsaderm ACE-All Blue is OLP.

其他以 Nutra Luxe MD, LLC 為申請人之記錄

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相關器械（代碼：OLP）

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。

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官方來源

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