FDA 510(k)

Fractional CO2 Laser Machine

K号: K250782 · 2025-06-12

申请人Zhengzhou PZ Laser Slim Technology Co., Ltd.

决定日期2025-06-12

产品代码GEX

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决定实质等同

器械摘要

Fractional CO2 Laser Machine is the device name listed in this FDA 510(k) record. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-06-12 under 510(k) number K250782. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Fractional CO2 Laser Machine?

Fractional CO2 Laser Machine is a medical device that received FDA 510(k) clearance on 2025-06-12. The listed applicant is Zhengzhou PZ Laser Slim Technology Co., Ltd.. The 510(k) number is K250782.

When did Fractional CO2 Laser Machine receive FDA 510(k) clearance?

Fractional CO2 Laser Machine received FDA 510(k) clearance on 2025-06-12, under 510(k) number K250782.

Who is the listed applicant for Fractional CO2 Laser Machine?

FDA 510(k)记录将郑州普泽激光瘦身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 Fractional CO2 Laser Machine?

The FDA product code for Fractional CO2 Laser Machine is GEX. This falls under the Gastroenterology category.

列明Zhengzhou PZ Laser Slim 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。

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官方来源

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