FDA 510(k)

Alma FemiLift Pixel CO2激光系统，输送装置和附件

K号: K250071 · 2025-09-24

决定日期2025-09-24

产品代码GEX

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决定实质等同

器械摘要

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2025-09-24 under 510(k) number K250071. 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 Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K250071.

When did Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories receive FDA 510(k) clearance?

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories received FDA 510(k) clearance on 2025-09-24, under 510(k) number K250071.

Who is the listed applicant for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

The FDA 510(k) record lists Alma Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

The FDA product code for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is GEX. This falls under the Gastroenterology category.

列明Alma Lasers, Inc.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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