Medical Device Manufacturer · US , Buffalo Grove , IL

Alma Lasers, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 2010
19
Total
19
Cleared
0
Denied

FDA 510(k) cleared devices by Alma Lasers, Inc. General & Plastic Surgery

18 devices
1-18 of 18
Cleared Sep 24, 2025
Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories
K250071 · GEX
General & Plastic Surgery · 257d
Cleared May 21, 2025
The Alma Hybrid Laser System
K251230 · GEX
General & Plastic Surgery · 30d
Cleared Apr 11, 2025
Alma Harmony
K243044 · GEX
General & Plastic Surgery · 196d
Cleared Feb 08, 2024
Alma Harmony
K233024 · GEX
General & Plastic Surgery · 139d
Cleared Mar 01, 2023
Alma Harmony
K230308 · GEX
General & Plastic Surgery · 26d
Cleared Feb 22, 2023
The Alma Soprano Titanium
K230371 · GEX
General & Plastic Surgery · 9d
Cleared Oct 12, 2022
The Alma Soprano Titanium
K222064 · GEX
General & Plastic Surgery · 91d
Cleared Oct 27, 2021
The Alma Opus System, Colibri Applicator and Tips
K201520 · GEI
General & Plastic Surgery · 506d
Cleared Jun 13, 2018
Harmony XL Multi-Application Platform
K181298 · ONF
General & Plastic Surgery · 28d
Cleared Jan 09, 2018
Modified Alma Lasers Soprano XL™ Family ofMulti-Application &...
K172193 · GEX
General & Plastic Surgery · 172d
Cleared Jul 14, 2017
Alma LipoFlow System
K171242 · MUU
General & Plastic Surgery · 78d
Cleared May 31, 2017
Modified Alma Lasers Soprano XL Family of Multi-Application &...
K170626 · GEX
General & Plastic Surgery · 90d
Cleared Sep 21, 2012
ALMA LASERS FAMILY OF PIXEL RF TIPS
K121150 · GEI
General & Plastic Surgery · 158d
Cleared Mar 08, 2012
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K113810 · PDZ
General & Plastic Surgery · 76d
Cleared Sep 13, 2011
ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH...
K112031 · GEX
General & Plastic Surgery · 60d
Cleared Jan 21, 2011
MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM
K101147 · NUV
General & Plastic Surgery · 273d
Cleared Jan 14, 2011
ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES
K103501 · GEX
General & Plastic Surgery · 46d
Cleared Sep 28, 2010
MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS
K102716 · GEX
General & Plastic Surgery · 7d
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