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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K250071
Device Name Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
Applicant
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Applicant Contact Jessica Rivera-Montejo
Correspondent
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Correspondent Contact Jessica Rivera-Montejo
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/10/2025
Decision Date 09/24/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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