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

Alma Lasers, Inc. has 19 FDA 510(k) cleared general & plastic surgery devices. Based in Buffalo Grove, US.

Latest FDA clearance: Sep 2025. Active since 2010.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Kathy Maynor Consulting as regulatory consultant.

FDA 510(k) Regulatory Record - Alma Lasers, Inc.
19 devices
1-19 of 19
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 Aug 17, 2016
Accent XL
K160075 · IMI
Physical Medicine · 216d
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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