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FDA 510(k)

IPL家用脫毛設備（SJ15）

K 號：K240093 · 2024-04-24

申請人Shenzhen Shuge Medical Beauty Devices Co., Ltd.
決定日期2024-04-24
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 Home Use Hair Removal Device (SJ15) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Shuge Medical Beauty Devices Co., Ltd.. It received FDA 510(k) clearance on 2024-04-24 under 510(k) number K240093. 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 Home Use Hair Removal Device (SJ15)?

IPL Home Use Hair Removal Device (SJ15) is a medical device that received FDA 510(k) clearance on 2024-04-24. The listed applicant is Shenzhen Shuge Medical Beauty Devices Co., Ltd.. The 510(k) number is K240093.

When did IPL Home Use Hair Removal Device (SJ15) receive FDA 510(k) clearance?

IPL Home Use Hair Removal Device (SJ15) received FDA 510(k) clearance on 2024-04-24, under 510(k) number K240093.

Who is the listed applicant for IPL Home Use Hair Removal Device (SJ15)?

The FDA 510(k) record lists Shenzhen Shuge Medical Beauty Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Home Use Hair Removal Device (SJ15)?

The FDA product code for IPL Home Use Hair Removal Device (SJ15) is OHT.

相關臨床試驗

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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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