Data / Medical devices / Israel / Alma Lasers Ltd.
Alma Lasers Ltd.: FDA-registered device maker in CAESAREA Northern, Israel, 44 510(k) clearances
Alma Lasers Ltd. is registered with the FDA (registration 3004167969) in CAESAREA Northern, Israel. It lists 18 device types. The FDA files 44 510(k) clearances under its listings, the newest dated June 5, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004167969
- Address
- 18 Haharash Street NORTH INDUSTRIAL PARK, CAESAREA Northern, Israel, 3079895
- Owner or operator
- ALMA LASERS LTD. (9055441)
- Roles
- Complaint file establishment, Foreign private label distributor, Manufacturer
- First device listed
- September 29, 2003
- Registered through
- 2026
- Brand names listed
- 308 Dermatological Excimer System, Accent UniForm Massager Module, Alex 755 Harmony XL Module, Alma DUO, Alma Diode Tabletop Laser, Alma Family of Thermo XEL Handpieces, Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories, Alma Harmony and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 5, 2026 | K251684 | Alma TED+ System | OAP | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| September 24, 2025 | K250071 | Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| May 21, 2025 | K251230 | The Alma Hybrid Laser System | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| April 11, 2025 | K243044 | Alma Harmony | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| February 8, 2024 | K233024 | Alma Harmony | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| August 14, 2023 | K231054 | V-Laser | GEX | Substantially Equivalent | Wontech Co., Ltd. | accessdata.fda.gov |
| March 1, 2023 | K230308 | Alma Harmony | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| February 22, 2023 | K230371 | The Alma Soprano Titanium | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| January 27, 2023 | K210166 | Omnispec ED1000 | ISA | Substantially Equivalent | Medispec, Ltd. | accessdata.fda.gov |
| October 12, 2022 | K222064 | The Alma Soprano Titanium | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| August 24, 2022 | K221427 | V-Laser | GEX | Substantially Equivalent | Wontech Co., Ltd. | accessdata.fda.gov |
| July 14, 2022 | K212073 | Alma Diode Tabletop Laser | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| October 27, 2021 | K201520 | The Alma Opus System, Colibri Applicator and Tips | GEI | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| July 2, 2021 | K203441 | The Alma Hybrid Laser System | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| June 13, 2018 | K181298 | Harmony XL Multi-Application Platform | ONF | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| January 9, 2018 | 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 | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| July 14, 2017 | K171242 | Alma LipoFlow System | MUU | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| June 15, 2017 | K170850 | Alma Q | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| May 31, 2017 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| August 17, 2016 | K160075 | Accent XL | IMI | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| May 5, 2016 | K160952 | Alma Diode Tabletop Laser | GEX | Substantially Equivalent | Alma, Ltd. | accessdata.fda.gov |
| March 13, 2015 | K141237 | HARMONY LITE | ONF | Substantially Equivalent | Alma, Inc. | accessdata.fda.gov |
| August 29, 2014 | K140009 | SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORM | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| July 18, 2014 | K140005 | ALMA DIODE TABLETOP LASER | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| September 21, 2012 | K121150 | ALMA LASERS FAMILY OF PIXEL RF TIPS | GEI | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| March 8, 2012 | K113810 | MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES | PDZ | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| September 13, 2011 | K112031 | ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| January 21, 2011 | K101147 | MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEM | NUV | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| January 14, 2011 | K103501 | ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| September 28, 2010 | K102716 | MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMS | GEX | Substantially Equivalent | Alma Lasers, Inc. | accessdata.fda.gov |
| October 29, 2009 | K090639 | EXELO2, MODEL 4010 | ONG | Substantially Equivalent | Quantel Derma GmbH | accessdata.fda.gov |
| August 13, 2009 | K090571 | ALMA LASERS ALEX755 MODULE | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| April 14, 2009 | K083848 | ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| January 12, 2009 | K082622 | ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULE | NUV | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| June 27, 2008 | K072182 | ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060 | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| May 23, 2008 | K072564 | ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM | GEX | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| December 26, 2007 | K073066 | 308 DERMATOLOGICAL EXCIMER SYSTEM | FTC | Substantially Equivalent | Quantel Medical, Inc. | accessdata.fda.gov |
| October 5, 2007 | K072699 | ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XL | GEI | Substantially Equivalent | Alma Lasers , Ltd. | accessdata.fda.gov |
| February 22, 2006 | K053604 | WAVELIGHT IDAS | GEX | Substantially Equivalent | Wavelight Laser Technologie AG | accessdata.fda.gov |
| December 21, 2004 | K042000 | MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS | GEX | Substantially Equivalent | Msq (M2) , Ltd. | accessdata.fda.gov |
| September 29, 2004 | K042474 | ARION | GEX | Substantially Equivalent | Wavelight Laser Technologie AG | accessdata.fda.gov |
| May 19, 2004 | K040433 | SINON | GEX | Substantially Equivalent | Wavelight Laser Technologie AG | accessdata.fda.gov |
| May 14, 2004 | K040384 | MYDON C | GEX | Substantially Equivalent | Wavelight Laser Technologie AG | accessdata.fda.gov |
| April 5, 2004 | K033946 | LOVELY SYSTEM | FTC | Substantially Equivalent | Msq (M2) , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lipoaspirate Washing System For Aesthetic Body Contouring
- All makers of Light, Ultraviolet, Dermatological
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Massager, Therapeutic, Electric
Updated June 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.