FDA 510(k)

Hair Removal Device, Model(s): R2815-G Pro, R2815-G

K号: K232575 · 2023-11-20

申请人Shenzhen Jianchao Intelligent Technology Co., Ltd.

决定日期2023-11-20

产品代码OHT

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决定实质等同

器械摘要

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.

常见问题

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)记录将深圳健超智能科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

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.

列明Shenzhen Jianchao Intelligent Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K261705脱毛设备（R3C16-G Pro，R3C16-V Pro）K253833面部与身体美容设备（型号：INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507）K252553面部与身体美容设备（INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507）K242710Hair 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)

相关器械（代码：OHT）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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