FDA 510(k)

Alma FemiLift Pixel CO2 レーザーシステム、デリバリデバイスおよびアクセサリー

K番号: K250071 · 2025-09-24

決定日2025-09-24

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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.

よくある質問

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.