K250071

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

510(k) number
K250071
Device name
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
Applicant
Alma Lasers, Inc. IL · US
Product code
GEX — Powered Laser Surgical Instrument
Decision date
2025-09-24
Date received
2025-01-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain

Also available from FDA: K250071.pdf

Official FDA record: K250071
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.