FDA 510(k)

Sistema de Laser de CO2 Alma FemiLift Pixel, Dispositivos de Entrega e Acessórios

Número K: K250071 · 2025-09-24

Data da decisão2025-09-24

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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