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FDA 510(k)

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

K-Number: K250071 · 2025-09-24

ApplicantAlma Lasers, Inc.
Decision Date2025-09-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2025-09-24 under approval 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.

Frequently Asked Questions

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. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K250071.

When was Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories approved by the FDA?

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

What company makes Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories is manufactured by Alma Lasers, Inc..

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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Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41813232 Artificial Intelligence Applications in Medical Devices for Personalized Health Care Solutions: Systematic Review. Journal of medical Internet research (2026) PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026) PMID: 41518328 Surface Energy and Pinning Forces of Fluorine-Free, Water-Friendly Coatings for Medical Devices. Langmuir : the ACS journal of surfaces and colloids (2026)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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