FDA.report

ALMA LASERS LTD.

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30041679693004167969ALMA LASERS LTD.1N2026-01-0118 Haharash Street NORTH INDUSTRIAL PARK CAESAREA Northern IL 3079895

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
616131427072114K251230The Alma Hybrid Laser SystemGEX2025-05-21
616131650672597K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX2025-09-24
616131162130441K243044Alma HarmonyGEX2025-04-11
616131767869722K233024Alma HarmonyGEX2024-02-08
616131059036982K231054V-LaserGEX2023-08-14
616131885206728K230371The Alma Soprano TitaniumGEX2023-02-22
616131559304238K230308Alma HarmonyGEX2023-03-01
616131884077608K222064The Alma Soprano TitaniumGEX2022-10-12
616131646585824K221427V-LaserGEX2022-08-24
616131452701739K212073Alma Diode Tabletop LaserGEX2022-07-14
616131982496457K210166Omnispec ED1000ISA2023-01-27
616131409656281K203441The Alma Hybrid Laser SystemGEX2021-07-02
616131790943264K201520The Alma Opus System, Colibri Applicator and TipsGEI2021-10-27
616131431823433K181298Harmony XL Multi-Application PlatformONF2018-06-13
616131431823433K181298Harmony XL Multi-Application PlatformONF2018-06-13
616131881400754K172193Modified 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 ModulesGEX2018-01-09
616131881400754K172193Modified 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 ModulesGEX2018-01-09
616131521735416K171242Alma LipoFlow SystemMUU2017-07-14
616131521735416K171242Alma LipoFlow SystemMUU2017-07-14
616131156516495K170850Alma QGEX2017-06-15
616131156516495K170850Alma QGEX2017-06-15
616131549514875K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand pieceGEX2017-05-31
616131549514875K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand pieceGEX2017-05-31
616131460977159K160952Alma Diode Tabletop LaserGEX2016-05-05
616131460977159K160952Alma Diode Tabletop LaserGEX2016-05-05
616131003738856K160075Accent XLIMI2016-08-17
616131003738856K160075Accent XLIMI2016-08-17
616131037581768K141237HARMONY LITEONF2015-03-13
616131037581768K141237HARMONY LITEONF2015-03-13
616131061595844K140009SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORMGEX2014-08-29
616131061595844K140009SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORMGEX2014-08-29
616131328754010K140005ALMA DIODE TABLETOP LASERGEX2014-07-18
616131328754010K140005ALMA DIODE TABLETOP LASERGEX2014-07-18
616131187486018K121150ALMA LASERS FAMILY OF PIXEL RF TIPSGEI2012-09-21
616131187486018K121150ALMA LASERS FAMILY OF PIXEL RF TIPSGEI2012-09-21
616131927607967K113810MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULESPDZ2012-03-08
616131927607967K113810MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULESPDZ2012-03-08
616131535359287K112031ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATIONGEX2011-09-13
616131535359287K112031ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATIONGEX2011-09-13
616131217027251K103501ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIESGEX2011-01-14
616131217027251K103501ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIESGEX2011-01-14
616131209261723K102716MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMSGEX2010-09-28
616131209261723K102716MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMSGEX2010-09-28
616131556090801K101147MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMNUV2011-01-21
616131556090801K101147MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMNUV2011-01-21
616132014524507K090762LEDAGEX2009-08-28
616131641982669K090639EXELO2, MODEL 4010ONG2009-10-29
616131641982669K090639EXELO2, MODEL 4010ONG2009-10-29
616131308850261K090571ALMA LASERS ALEX755 MODULEGEX2009-08-13
616131308850261K090571ALMA LASERS ALEX755 MODULEGEX2009-08-13
616131942805880K083848ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORMGEX2009-04-14
616131942805880K083848ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORMGEX2009-04-14
616131276498640K082622ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULENUV2009-01-12
616131276498640K082622ALMA LASERS ACCENT B-SHAPE MASSAGER HANDPIECE/MODULENUV2009-01-12
616131921926675K080463ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIESGEX2008-07-23
616131428433652K080318ALMA LASER NIR MODULEILY2008-03-07
616132051051590K073066308 DERMATOLOGICAL EXCIMER SYSTEMFTC2007-12-26
616132051051590K073066308 DERMATOLOGICAL EXCIMER SYSTEMFTC2007-12-26
616131124342102K072699ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XLGEI2007-10-05
616131124342102K072699ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XLGEI2007-10-05
616131167577218K072564ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORMGEX2008-05-23
616131167577218K072564ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORMGEX2008-05-23
616131623077454K072182ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060GEX2008-06-27
616131623077454K072182ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060GEX2008-06-27
616131593602054K070004ACCENTGEI2007-04-23
616131840332694K053604WAVELIGHT IDASGEX2006-02-22
616131840332694K053604WAVELIGHT IDASGEX2006-02-22
616132068930606K052874SOPRANO HAIR REMOVAL DIODE LASERGEX2005-11-22
616131535167408K052806BURANEGEX2005-10-17
616131329026941K050317BURANE XLGEX2005-02-24
616131034286118K050218WAVELIGHT SINONGEX2005-02-15
616131373730512K042474ARIONGEX2004-09-29
616131373730512K042474ARIONGEX2004-09-29
616131606007209K042000MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMSGEX2004-12-21
616131606007209K042000MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMSGEX2004-12-21
616131947156436K040433SINONGEX2004-05-19
616131947156436K040433SINONGEX2004-05-19
616131223437314K040384MYDON CGEX2004-05-14
616131223437314K040384MYDON CGEX2004-05-14
616131029701549K033946LOVELY SYSTEMFTC2004-04-05
616131029701549K033946LOVELY SYSTEMFTC2004-04-05
616131810129209K032260ARAMIS II DERMATOLOGICAL LASERGEX2003-11-20
616131090023013K031819DIO-DENT 10 DENTAL DIODE LASERGEX2003-10-30
616131115280972K030805MYTHOS 500GEX2003-05-21
616131315830826K023734ARAMIS II DERMATOLOGICAL LASERGEX2003-05-06
616131156150969BK220713
616132030238543BK220668
616131405194802
616131716367332
616131862824984

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
GEX572025-09-24
GEI62021-10-27
ONF42018-06-13
NUV42011-01-21
FTC42007-12-26
MUU22017-07-14
IMI22016-08-17
PDZ22012-03-08
ONG22009-10-29
ISA12023-01-27
ILY12008-03-07

PMA

PMN

ACCENT

2007-04-23

ALMA LASERS LTD.

Applications

GUDID