FDA 510(k) Applications Submitted by ALMA LASERS INC.

FDA 510(k) Number Submission Date Device Name Applicant
K160075 01/14/2016 Accent XL Alma Lasers Inc.
K230371 02/13/2023 The Alma Soprano Titanium Alma Lasers Inc.
K201520 06/08/2020 The Alma Opus System, Colibri Applicator and Tips Alma Lasers Inc.
K222064 07/13/2022 The Alma Soprano Titanium Alma Lasers Inc.
K121150 04/16/2012 ALMA LASERS FAMILY OF PIXEL RF TIPS ALMA LASERS INC.
K170626 03/02/2017 Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece Alma Lasers Inc.
K171242 04/27/2017 Alma LipoFlow System Alma Lasers Inc.
K181298 05/16/2018 Harmony XL Multi-Application Platform Alma Lasers Inc.
K172193 07/21/2017 Modified Alma Lasers Soprano XLÖ 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 Modules Alma Lasers Inc.
K113810 12/23/2011 MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES ALMA LASERS INC.


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