510(k) Report

FDA applicant

Alma Lasers, Inc.

Buffalo Grove, IL34 decisions2007–20260 recalls

FDA records 34 decisions for Alma Lasers, Inc. (Buffalo Grove, IL) from 2007 to 2026: 34 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 156 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 127 predicates, 40 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Alma Lasers , Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Alma Lasers, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2007: 22008: 42009: 32010: 12011: 32012: 22014: 22016: 12017: 32018: 22021: 22022: 22023: 22024: 12025: 32026 (partial year): 1
2007high 4 (2008) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Alma Lasers, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Alma Lasers, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument22decisions
  • GEIElectrosurgical, Cutting & Coagulation & Accessories4decisions
  • NUVMassager, Vacuum, Light Induced Heating2decisions
  • ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1decision
  • PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis1decision
  • MUUSystem, Suction, Lipoplasty1decision

Also: ILY (1), IMI (1), OAP (1).

How long do its 510(k) reviews take?

Since 2016, its 16 510(k)s took a median of 156 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 6 of its 16 were faster than that.

Whose devices does it build on?

Its devices cite 127 predicates; 40 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 112 times; 40 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 200820cite it
  • K070004AccentAlma Lasers, Ltd. · 200712cite it
  • K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 20229cite it
  • K072699Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLAlma Lasers, Ltd. · 20077cite it
  • K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL…Alma Lasers, Inc. · 20117cite it
  • K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL…Alma Lasers, Inc. · 20187cite it

What has FDA decided for it lately?

  • K251684Alma TED+ SystemAlma Lasers, Inc. · 2026
  • K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesAlma Lasers, Inc. · 2025
  • K251230The Alma Hybrid Laser SystemAlma Lasers, Inc. · 2025
  • K243044Alma HarmonyAlma Lasers, Inc. · 2025
  • K233024Alma HarmonyAlma Lasers, Inc. · 2024
  • K230308Alma HarmonyAlma Lasers, Inc. · 2023
  • K230371The Alma Soprano TitaniumAlma Lasers, Inc. · 2023
  • K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022

All 20 as Alma Lasers, Inc. →All 14 as Alma Lasers, Ltd. →

Other applicant names beginning “Alma”

FDA records each applicant name separately; these may or may not be the same firm.

Alma, Inc. 2