FDA.reportPublic FDA data

ALMA LASERS LTD.

Matched from indexed company URL: Alma Lasers Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041679693004167969ALMA LASERS LTD.1N2026-01-0118 Haharash Street NORTH INDUSTRIAL PARK CAESAREA Northern IL 3079895
30044506613004450661ALMA LASERS, INC.1Y2026-01-01485 Half Day Rd Ste 100 BUFFALO GROVE IL US 60089

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
616131427072114K251230The Alma Hybrid Laser SystemGEX2025-05-21
630911846184165K251094Alma VeilGEX2025-05-06
630911754044798K250125LMNT O2OHS2025-03-24
616131650672597K250071Alma FemiLift Pixel CO2 Laser System, Delivery Devices and AccessoriesGEX2025-09-24
616131162130441K243044Alma HarmonyGEX2025-04-11
616131767869722K233024Alma HarmonyGEX2024-02-08
616131059036982K231054V-LaserGEX2023-08-14
630911444246710K231054V-LaserGEX2023-08-14
616131885206728K230371The Alma Soprano TitaniumGEX2023-02-22
616131559304238K230308Alma HarmonyGEX2023-03-01
616131884077608K222064The Alma Soprano TitaniumGEX2022-10-12
630911597652521K221427V-LaserGEX2022-08-24
616131646585824K221427V-LaserGEX2022-08-24
616131452701739K212073Alma Diode Tabletop LaserGEX2022-07-14
630911479696318K210166Omnispec ED1000ISA2023-01-27
616131982496457K210166Omnispec ED1000ISA2023-01-27
616131409656281K203441The Alma Hybrid Laser SystemGEX2021-07-02
616131790943264K201520The Alma Opus System, Colibri Applicator and TipsGEI2021-10-27
630911698772102K181659Avologi ENEOOHS2018-07-26
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
616131521735416K171242Alma LipoFlow SystemMUU2017-07-14
616131156516495K170850Alma QGEX2017-06-15
616131549514875K170626Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand pieceGEX2017-05-31
616131460977159K160952Alma Diode Tabletop LaserGEX2016-05-05
616131003738856K160075Accent XLIMI2016-08-17
616131037581768K141237HARMONY LITEONF2015-03-13
616131061595844K140009SOPRANO ICE MULTI-APPLICATION & MULTI-TECHNOLOGY PLATFORMGEX2014-08-29
616131328754010K140005ALMA DIODE TABLETOP LASERGEX2014-07-18
616131187486018K121150ALMA LASERS FAMILY OF PIXEL RF TIPSGEI2012-09-21
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
616131217027251K103501ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIESGEX2011-01-14
616131209261723K102716MODIFIED ALMA LASERS FAMILY OF SOPRANO XL MULTI-APPLICATION PLATMFORMSGEX2010-09-28
616131556090801K101147MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMNUV2011-01-21
616132014524507K090762LEDAGEX2009-08-28
616131641982669K090639EXELO2, MODEL 4010ONG2009-10-29
616131308850261K090571ALMA LASERS ALEX755 MODULEGEX2009-08-13
616131942805880K083848ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORMGEX2009-04-14
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
616131124342102K072699ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMS, MODELS: ACCENT, ACCENT XLGEI2007-10-05
616131167577218K072564ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORMGEX2008-05-23
616131623077454K072182ALMA LASERS FAMILY OF THERMO-XEL HANDPIECES, PIXEL MODELS: 2940, 1060GEX2008-06-27
616131593602054K070004ACCENTGEI2007-04-23
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
616131606007209K042000MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMSGEX2004-12-21
616131947156436K040433SINONGEX2004-05-19
616131223437314K040384MYDON CGEX2004-05-14
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
630911178524074
616131405194802
616131716367332
616131862824984

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX602025-09-24
GEI62021-10-27
ONF42018-06-13
NUV42011-01-21
FTC42007-12-26
OHS22025-03-24
ISA22023-01-27
MUU22017-07-14
IMI22016-08-17
PDZ22012-03-08
ONG22009-10-29
ILY12008-03-07

PMN#

Alma Q

2017-06-15

Alma Lasers LTD

ACCENT

2007-04-23

ALMA LASERS LTD.

GUDID#

Soprano Titanium System 230V - The Alma Lasers Soprano Titanium Laser System consists of:•System console (contains the laser diodes, the system software, power supply, andvarious other electronic and mechanical parts)•Operator control panel with touch-screen technology (GUI)•Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneouslyPremarket Notification Traditional 510(k) Section 8: Page 2 of 4Alma Lasers Soprano Titanium• 810 nm applicator• 755 nm applicator• Small NIR applicator• Footswitch and other laser safety accessories

ALMA LASERS LTD.

2022-11-06

Accent Prime Ultra Applicator for Inc. - The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

ALMA LASERS LTD.

2022-11-22

Accent Prime MiniSpeed Applicator for Inc. - The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

ALMA LASERS LTD.

2022-11-22

Accent Prime UltraSpeed Applicator for Inc. - The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

ALMA LASERS LTD.

2022-11-22

Accent Prime System 120V For Inc. - The Alma Lasers Accent is a console with three previously cleared RF hand piecesand one ultrasound hand piece that is the subject of this submission. The previouslycleared hand pieces have not changed from what was cleared in their associated 510(k)submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with afrequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console showsthe treatments that have been chosen and when the output is active.

ALMA LASERS LTD.

2022-11-22

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