FDA 510(k)

Pulsaderm 痤瘡面膜 28，Pulsaderm 痤瘡面膜 37

K 號：K170111 · 2017-05-08

決定日期2017-05-08

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 Acne Mask 28 , Pulsaderm Acne Mask 37 is the device name listed in this FDA 510(k) record. The listed applicant is Pulsaderm, LLC. It received FDA 510(k) clearance on 2017-05-08 under 510(k) number K170111. 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 Acne Mask 28 , Pulsaderm Acne Mask 37?

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is a medical device that received FDA 510(k) clearance on 2017-05-08. The listed applicant is Pulsaderm, LLC. The 510(k) number is K170111.

When did Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 receive FDA 510(k) clearance?

Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 received FDA 510(k) clearance on 2017-05-08, under 510(k) number K170111.

Who is the listed applicant for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37?

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

What is the FDA product code for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37?

The FDA product code for Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37 is OLP.

其他以 Pulsaderm, LLC 為申請人之記錄

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K182501髮激光頭帶 K163329Pulsaderm皺紋面膜28，Pulsaderm皺紋面膜72

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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