Alma Lasers , Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
33
Inspections
2
Compliance Actions
1

Recent 510(k) Clearances

K-NumberDeviceDate
K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesSeptember 24, 2025
K251230The Alma Hybrid Laser SystemMay 21, 2025
K243044Alma HarmonyApril 11, 2025
K233024Alma HarmonyFebruary 8, 2024
K230308Alma HarmonyMarch 1, 2023
K230371The Alma Soprano TitaniumFebruary 22, 2023
K222064The Alma Soprano TitaniumOctober 12, 2022
K212073Alma Diode Tabletop LaserJuly 14, 2022
K201520The Alma Opus System, Colibri Applicator and TipsOctober 27, 2021
K203441The Alma Hybrid Laser SystemJuly 2, 2021
K181298Harmony XL Multi-Application PlatformJune 13, 2018
K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL,January 9, 2018
K171242Alma LipoFlow SystemJuly 14, 2017
K170850Alma QJune 15, 2017
K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAGMay 31, 2017
K160075Accent XLAugust 17, 2016
K140009SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORMAugust 29, 2014
K140005ALMA DIODE TABLETOP LASERJuly 18, 2014
K121150ALMA LASERS FAMILY OF PIXEL RF TIPSSeptember 21, 2012
K113810MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULESMarch 8, 2012