FDA 510(k)

强脉冲光治疗系统

K号: K230816 · 2023-04-21

申请人Shangdong Huamei Technology Co., Ltd.

决定日期2023-04-21

产品代码ONF

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

Intense Pulsed Light Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Shangdong Huamei Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-04-21 under 510(k) number K230816. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Intense Pulsed Light Treatment System?

Intense Pulsed Light Treatment System is a medical device that received FDA 510(k) clearance on 2023-04-21. The listed applicant is Shangdong Huamei Technology Co., Ltd.. The 510(k) number is K230816.

When did Intense Pulsed Light Treatment System receive FDA 510(k) clearance?

Intense Pulsed Light Treatment System received FDA 510(k) clearance on 2023-04-21, under 510(k) number K230816.

Who is the listed applicant for Intense Pulsed Light Treatment System?

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

What is the FDA product code for Intense Pulsed Light Treatment System?

The FDA product code for Intense Pulsed Light Treatment System is ONF.

列明Shangdong Huamei 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。

K202758Nd: YAG 激光治疗系统 HM-YL900 K200751光动力疗法（PDT）设备 K192521强脉冲光治疗系统 K192528CO2 激光治疗系统

官方来源

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