FDA 510(k)

除毛設備（型號：IPL-D26，IPL-D19）

K 號：K221643 · 2022-10-21

決定日期2022-10-21

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

Hair Removal Device (Model: IPL-D26, IPL-D19) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Desida Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-21 under 510(k) number K221643. 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 Hair Removal Device (Model: IPL-D26, IPL-D19)?

Hair Removal Device (Model: IPL-D26, IPL-D19) is a medical device that received FDA 510(k) clearance on 2022-10-21. The listed applicant is Shenzhen Desida Technology Co., Ltd.. The 510(k) number is K221643.

When did Hair Removal Device (Model: IPL-D26, IPL-D19) receive FDA 510(k) clearance?

Hair Removal Device (Model: IPL-D26, IPL-D19) received FDA 510(k) clearance on 2022-10-21, under 510(k) number K221643.

Who is the listed applicant for Hair Removal Device (Model: IPL-D26, IPL-D19)?

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

What is the FDA product code for Hair Removal Device (Model: IPL-D26, IPL-D19)?

The FDA product code for Hair Removal Device (Model: IPL-D26, IPL-D19) is OHT.

其他以 Shenzhen Desida Technology 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。

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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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