Company · US
Alma Lasers, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2026. Name variants (Inc, Corp, punctuation) are merged.
34510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GEX | Powered Laser Surgical Instrument | 22 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 |
| NUV | Massager, Vacuum, Light Induced Heating | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 |
| MUU | System, Suction, Lipoplasty | 1 |
| OAP | Laser, Comb, Hair | 1 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 5, 2026 | K251684 | Alma TED+ System Alma Lasers, Inc. | OAP |
| Sep 24, 2025 | K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories Alma Lasers, Inc. | GEX |
| May 21, 2025 | K251230 | The Alma Hybrid Laser System Alma Lasers, Inc. | GEX |
| Apr 11, 2025 | K243044 | Alma Harmony Alma Lasers, Inc. | GEX |
| Feb 8, 2024 | K233024 | Alma Harmony Alma Lasers, Inc. | GEX |
| Mar 1, 2023 | K230308 | Alma Harmony Alma Lasers, Inc. | GEX |
| Feb 22, 2023 | K230371 | The Alma Soprano Titanium Alma Lasers, Inc. | GEX |
| Oct 12, 2022 | K222064 | The Alma Soprano Titanium Alma Lasers, Inc. | GEX |
| Jul 14, 2022 | K212073 | Alma Diode Tabletop Laser Alma Lasers , Ltd., IL | GEX |
| Oct 27, 2021 | K201520 | The Alma Opus System, Colibri Applicator and Tips Alma Lasers, Inc. | GEI |
| Jul 2, 2021 | K203441 | The Alma Hybrid Laser System Alma Lasers , Ltd., IL | GEX |
| Jun 13, 2018 | K181298 | Harmony XL Multi-Application Platform Alma Lasers, Inc. | ONF |
| Jan 9, 2018 | K172193 | Modified Alma Lasers Soprano XL Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, Soprano Alma Lasers, Inc. | GEX |
| Jul 14, 2017 | K171242 | Alma LipoFlow System Alma Lasers, Inc. | MUU |
| Jun 15, 2017 | K170850 | Alma Q Alma Lasers , Ltd., IL | GEX |
| May 31, 2017 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece Alma Lasers, Inc. | GEX |
| Aug 17, 2016 | K160075 | Accent XL Alma Lasers, Inc. | IMI |
| Aug 29, 2014 | K140009 | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM Alma Lasers , Ltd. | GEX |
| Jul 18, 2014 | K140005 | ALMA DIODE TABLETOP LASER Alma Lasers , Ltd. | GEX |
| Sep 21, 2012 | K121150 | ALMA LASERS FAMILY OF PIXEL RF TIPS Alma Lasers, Inc. | GEI |
| Mar 8, 2012 | K113810 | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES Alma Lasers, Inc. | PDZ |
| Sep 13, 2011 | K112031 | ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION Alma Lasers, Inc. | GEX |
| Jan 21, 2011 | K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM Alma Lasers, Inc. | NUV |
| Jan 14, 2011 | K103501 | ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES Alma Lasers, Inc. | GEX |
| Sep 28, 2010 | K102716 | MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS Alma Lasers, Inc. | GEX |
| Aug 13, 2009 | K090571 | ALMA LASERS ALEX755 MODULE Alma Lasers , Ltd. | GEX |
| Apr 14, 2009 | K083848 | ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM Alma Lasers , Ltd., IL | GEX |
| Jan 12, 2009 | K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE Alma Lasers , Ltd. | NUV |
| Jul 23, 2008 | K080463 | ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES Alma Lasers , Ltd. | GEX |
| Jun 27, 2008 | K072182 | ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 Alma Lasers , Ltd. | GEX |
| May 23, 2008 | K072564 | ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM Alma Lasers , Ltd. | GEX |
| Mar 7, 2008 | K080318 | ALMA LASER NIR MODULE Alma Lasers , Ltd., IL | ILY |
| Oct 5, 2007 | K072699 | ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL Alma Lasers , Ltd. | GEI |
| Apr 23, 2007 | K070004 | ACCENT Alma Lasers , Ltd. | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||