FDA 510(k)

除毛設備（R3C16-P、R3C16-W、R3C16-G、R3C16-P Pro、R3C16-W Pro、R3C16-G Pro、R3505-W、R3505-B、R3505-W Pro、R3505-B Pro）

K 號：K242710 · 2024-12-06

申請人Shenzhen Jianchao Intelligent Technology Co., Ltd.

決定日期2024-12-06

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

Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jianchao Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-12-06 under 510(k) number K242710. 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 (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)?

Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) is a medical device that received FDA 510(k) clearance on 2024-12-06. The listed applicant is Shenzhen Jianchao Intelligent Technology Co., Ltd.. The 510(k) number is K242710.

When did Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) receive FDA 510(k) clearance?

Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) received FDA 510(k) clearance on 2024-12-06, under 510(k) number K242710.

Who is the listed applicant for Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)?

FDA 510(k) 記錄將深圳健超智能技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro)?

The FDA product code for Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) is OHT.

其他以 Shenzhen Jianchao Intelligent 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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官方來源

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