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FDA 510(k)

IPL美髮減脫系統

K 號：K181568 · 2018-09-11

申請人Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt
決定日期2018-09-11
產品代碼OHT
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

IPL Salon Hair Reduction System is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K181568. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IPL Salon Hair Reduction System?

IPL Salon Hair Reduction System is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt. The 510(k) number is K181568.

When did IPL Salon Hair Reduction System receive FDA 510(k) clearance?

IPL Salon Hair Reduction System received FDA 510(k) clearance on 2018-09-11, under 510(k) number K181568.

Who is the listed applicant for IPL Salon Hair Reduction System?

The FDA 510(k) record lists Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Salon Hair Reduction System?

The FDA product code for IPL Salon Hair Reduction System is OHT.

相關臨床試驗

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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相關器械（代碼：OHT）

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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