FDA 510(k)

除毛設備，型號：R2815-G Pro，R2815-G

K 號：K232575 · 2023-11-20

申請人Shenzhen Jianchao Intelligent Technology Co., Ltd.

決定日期2023-11-20

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(s): R2815-G Pro, R2815-G 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 2023-11-20 under 510(k) number K232575. 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(s): R2815-G Pro, R2815-G?

Hair Removal Device, Model(s): R2815-G Pro, R2815-G is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is Shenzhen Jianchao Intelligent Technology Co., Ltd.. The 510(k) number is K232575.

When did Hair Removal Device, Model(s): R2815-G Pro, R2815-G receive FDA 510(k) clearance?

Hair Removal Device, Model(s): R2815-G Pro, R2815-G received FDA 510(k) clearance on 2023-11-20, under 510(k) number K232575.

Who is the listed applicant for Hair Removal Device, Model(s): R2815-G Pro, R2815-G?

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, Model(s): R2815-G Pro, R2815-G?

The FDA product code for Hair Removal Device, Model(s): R2815-G Pro, R2815-G 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。

K261705除毛設備（R3C16-G Pro, R3C16-V Pro）K253833臉部與身體美妝設備（型號：INIA-BD001、INIA-BD002、INIA-BD003、INIA-BD004、F2C15、F3222 Pro、F5516、F3606、F2210 Pro、F5808、INIA-ED001、INIA-ED002、INIA-BLD001、E1507）K252553臉部與身體美妝設備（INIA-BD001、INIA-BD002、INIA-BD003、INIA-BD004、F2C15、F3222 Pro、F5516、F3606、F2210 Pro、F5808、INIA-ED001、INIA-ED002、INIA-BLD001、E1507）K242710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）

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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