# Alma Lasers, Inc.

- Location (FDA's records): Buffalo Grove, IL
- FDA decisions: 34 (2007–2026): 34 510(k) clearances
- Names in FDA's records: Alma Lasers, Inc. (20); Alma Lasers , Ltd. (14)
- Product codes: GEX (22), GEI (4), NUV (2), ONF (1), PDZ (1), MUU (1), ILY (1), IMI (1), OAP (1)
- 510(k) review time since 2016: median 156 days, against 90 for FDA's reviews in the same codes and years (6 of 16 faster)
- Predicates its devices cite: 127 (40 its own); citations of its devices by later devices: 112 (40 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lumenis, Inc.: 12 (https://510kreport.com/company/lumenis)
- Syneron Medical, Ltd.: 6 (https://510kreport.com/company/syneron-medical)
- Cutera, Inc.: 6 (https://510kreport.com/company/cutera)
- Msq (M2), Ltd.: 5 (https://510kreport.com/company/msq-m2)
- Cynosure, Inc.: 5 (https://510kreport.com/company/cynosure)
- Thermage, Inc.: 4 (https://510kreport.com/company/thermage)
- Alma, Inc.: 3 (https://510kreport.com/company/alma)
- Wavelight Laser Technologie AG: 3 (https://510kreport.com/company/wavelight-laser-technologie)

## Firms that cite its devices most
- Syneron Medical, Ltd.: 5 (https://510kreport.com/company/syneron-medical)
- High Technology Products S.L.U: 3 (https://510kreport.com/company/high-technology-products-slu)
- Alma, Inc.: 3 (https://510kreport.com/company/alma)
- BTL Industries, Inc.: 3 (https://510kreport.com/company/btl-industries)
- Solta Medical, Inc.: 3 (https://510kreport.com/company/solta-medical)
- El.En Electronic Engineering Spa: 3 (https://510kreport.com/company/el-en-electronic-engineering)
- Ellman Int'L, Inc.: 2 (https://510kreport.com/company/ellman-int-l)
- Sharplight Technologies, Ltd.: 2 (https://510kreport.com/company/sharplight-technologies)

## Its most-cited devices
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), cited by 20
- K070004: Accent (2007), cited by 12
- K222064: The Alma Soprano Titanium (2022), cited by 9
- K072699: Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XL (2007), cited by 7
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application (2011), cited by 7
- K172193: Modified Alma Lasers Soprano XL™ 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 (2018), cited by 7

## Recent decisions
- K251684: Alma TED+ System (Jun 5, 2026)
- K250071: Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories (Sep 24, 2025)
- K251230: The Alma Hybrid Laser System (May 21, 2025)
- K243044: Alma Harmony (Apr 11, 2025)
- K233024: Alma Harmony (Feb 8, 2024)
- K230308: Alma Harmony (Mar 1, 2023)
- K230371: The Alma Soprano Titanium (Feb 22, 2023)
- K222064: The Alma Soprano Titanium (Oct 12, 2022)

Source page: https://510kreport.com/company/alma-lasers