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FDA 510(k)

IPL家用脫毛設備，型號：JD-TM002、JD-TM003、JD-TM012、JD-TM016、JD-TM022

K 號：K231717 · 2023-09-06

申請人Foshan Jindi Electric Appliance Co., Ltd.
決定日期2023-09-06
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, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Jindi Electric Appliance Co., Ltd.. It received FDA 510(k) clearance on 2023-09-06 under 510(k) number K231717. 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, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022?

IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 is a medical device that received FDA 510(k) clearance on 2023-09-06. The listed applicant is Foshan Jindi Electric Appliance Co., Ltd.. The 510(k) number is K231717.

When did IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 receive FDA 510(k) clearance?

IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 received FDA 510(k) clearance on 2023-09-06, under 510(k) number K231717.

Who is the listed applicant for IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022?

The FDA 510(k) record lists Foshan Jindi Electric Appliance 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, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022?

The FDA product code for IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 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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其他以 Foshan Jindi Electric Appliance Co., Ltd. 為申請人之記錄

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。

K252209IPL家用脫毛設備（JD-TM016、JD-TM023、JD-TM027、JD-TM028、JD-TM032）

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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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