Name: Predicase
Price: 199 USD

K-number	K250071
Device name	Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
Applicant	Alma Lasers, Inc.
Product code	GEX
Device class	Class II
Decision date	Sep 24, 2025
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

Everything you need for a 510(k) submission. Nothing you don't.