Medical Device Manufacturer · US , Buffalo Grove , IL

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

20 submissions · 20 cleared · Since 2010

Recent clearances: Alma TED+ System, Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories, The Alma Hybrid Laser System

20
Total
20
Cleared
0
Denied

FDA 510(k) Regulatory Record - Alma Lasers, Inc. General & Plastic Surgery ✕

19 devices
1-12 of 19
Cleared Jun 05, 2026
Alma TED+ System
K251684 · OAP
General & Plastic Surgery · 368d
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
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