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Alma Lasers, Inc.

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories6
Latest FDA decision2026-06-05
TypeNumberDevice NameCodeDateActions
510(k) K251684 Alma TED+ SystemOAP2026-06-05 View
510(k) K250071 Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX2025-09-24 View
510(k) K251230 The Alma Hybrid Laser SystemGEX2025-05-21 View
510(k) K243044 Alma HarmonyGEX2025-04-11 View
510(k) K233024 Alma HarmonyGEX2024-02-08 View
510(k) K230308 Alma HarmonyGEX2023-03-01 View
510(k) K230371 The Alma Soprano TitaniumGEX2023-02-22 View
510(k) K222064 The Alma Soprano TitaniumGEX2022-10-12 View
510(k) K201520 The Alma Opus System, Colibri Applicator and TipsGEI2021-10-27 View
510(k) K181298 Harmony XL Multi-Application PlatformONF2018-06-13 View
510(k) K172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser ModulesGEX2018-01-09 View
510(k) K171242 Alma LipoFlow SystemMUU2017-07-14 View
510(k) K170626 Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand pieceGEX2017-05-31 View
510(k) K160075 Accent XLIMI2016-08-17 View
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