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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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