FDA 510(k)

手持式IPL设备（家用IPL脱毛设备），型号：FZ-608，FZ-608G，FZ-100，FZ-200

K号: K230739 · 2023-05-26

申请人Shenzhen Ionka Medical Technology Co., Ltd.

决定日期2023-05-26

产品代码OHT

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决定实质等同

器械摘要

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Ionka Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-26 under 510(k) number K230739. 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 Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200?

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 is a medical device that received FDA 510(k) clearance on 2023-05-26. The listed applicant is Shenzhen Ionka Medical Technology Co., Ltd.. The 510(k) number is K230739.

When did Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 receive FDA 510(k) clearance?

Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 received FDA 510(k) clearance on 2023-05-26, under 510(k) number K230739.

Who is the listed applicant for Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200?

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

What is the FDA product code for Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200?

The FDA product code for Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 is OHT.

列明Shenzhen Ionka Medical 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。

K221214手持式IPL设备（家用IPL脱毛设备）型号：FZ-608，FZ-608G，FZ-100，FZ-200

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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