FDA.reportPublic FDA data

LASER ENGINEERING, INC.

Matched from indexed company URL: LASER, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10608483000204219LASER ENGINEERING, INC.1N2026-01-01475 Metroplex Dr Ste 401 Nashville TN US 37211
12215431221543LASER PERIPHERALS LLC.1N2026-01-0113355 10th ave SUITE 110 Plymouth MN US 55441
21334501000520286Laservision USA, LP1Y2026-01-01595 Phalen Blvd Saint Paul MN US 55130
30036105273003610527Laser Dental Innovations1N2026-01-011219 Quail Creek Cir San Jose CA US 95120
30047690713004769071LASER BIOTECH INTERNATIONAL1Y2026-01-01830 Southlake Blvd Ste C North Chesterfield VA US 23236
30061510213006151021LASER NOVA AB1N2026-01-01Odenskogsvagen 1A Ostersund Jamtland SE 831 48
30077196563007719656LASER HEALTH TECHNOLOGIES1N2026-01-015268 E. Onyx Ave Paradise Valley AZ US 85253
30091346683009134668LASER THERAPY SERVICES, LLC1N2026-01-015233 Maple Springs Dr Chagrin Falls OH US 44022
30097365473009736547Laser Marketing Group, LLC1Y2026-01-01103 N. 1100 W. Lehi UT US 84043
30123294123012329412LASERPAIR CO.,LIMITED1N2026-01-015/F, Building B, Huifu Park, Pingji Road, Nanwan Street, Longgan Shenzhen Guangdong CN 518000
30135849943013584994LASER PHARMACEUTICALS1N2026-01-011015 Nine North Dr Ste 400 Alpharetta GA US 30004
30337531973033753197LASEROPTEK AMERICA CORP.1Y2026-01-0127071 Cabot Rd Ste 112 Laguna Hills CA US 92653
30068550483006855048LASER LOCATORS1Y2020-04-2513933 Lynmar Blvd Tampa FL US 33626
30154250583015425058LASER ASSOCIATED SCIENCES, INC.1N2020-04-255171 California Ave. Suite 150 Irvine CA US 92617

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00860011139706Laser Engineering - Re-usable fiberoptic handpiece for lasers5085202552r.rudko@laserengineering.com
00866988000285Laser Engineering - This device is an internally coated fusee silica waveguide used to deliver CO2 laser energy to the patient.5085202500customerinfo@laserengineering.com
00866988000292Laser Engineering - This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.5085202500customerinfo@laserengineering.com
10866988000299Laser Engineering - This device is an internally coated fused silica waveguide used to deliver CO2 laser energy to the patient.5085202500customerinfo@laserengineering.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
515291220598836P950015THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATIONMNO1998-08-20
735461152307293K993942LITESABER 2000GEX2000-01-18
16651194518655K992083SCATTERFREE LATERAL EMITTING FIBERGEX1999-07-12
16651493680678K974229LS-905 FIBERCHOICE ADAPTER SYSTEMGEX1998-02-10
16651350008587K972272LASER PERIPHERALS HOLMIUM BARE FIBERSGEX1997-07-29
16651151944489K961516LASER PERIPHERALS INC. BARE FIBERGEX1996-06-27
16651394253912K961079LASER PERIPHERALS INC. SCATTERFREE FIBERGEX1996-05-22
515291488615341K881588MODEL MD-25 LASER FOR SURGICAL USEGEX1988-06-03
515291593637223K881587MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONSGEX1988-06-03
515292050085430K881586MODEL MD-45 CO2 LASER FOR ENT APPLICATIONSGEX1988-06-03
515291528641955K881585MODEL MD-25 CO2 LASER FOR NEUROSURGERY USEGEX1988-06-03
515291799079942K881584MODEL MD-45 CO2 LASER FOR NEUROSURGERY USEGEX1988-06-03
515291282946268K881583MODEL MD-25 CO2 LASER FOR EAR, NOSE & THROATGEX1988-06-03
515291130679990K881582MODEL MD-45 CO2 LASER FOR DERMATOLOGY/PODIATRY USEGEX1988-06-03
515291910012496K881581MODEL MD-45 CO2 LASER FOR OB-GYN & UROLOGICAL USEGEX1988-06-03
515291386153206K881580MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERYGEX1988-06-03
1435831640990120K230990Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)GEX2023-06-01
1435831168586406K230308Alma HarmonyGEX2023-03-01
1435831324778552K220853PicoWay Laser SystemGEX2022-10-13
1435831538071490K212253Apollo Duet (Model : APD-4000)PBX2022-08-25
515291523003491K211605Dual SwitchGEX2022-09-22
1435831273789886K202988Tixel SystemGEI2021-02-25
1435831446047855K201111GentleMax Pro PlusGEX2020-05-26
1435831703166295K193426Elite iQGEX2020-03-09
2450921401339114K192966FlowMetDPW2020-01-10
1435831667684716K191528Venus Legacy Pro DeviceGEI2019-09-06
1435831095675463K191421Sofacia SystemOHV2019-09-09
2450921397043371K182494FlowMet-RDPW2019-02-27
1435831026855188K182365TempSure SystemGEI2018-10-24
1435831066340912K182173Joule SystemGEX2019-03-06
1435831722206953K181497HPM-6000UFKPI2018-11-14
1435831342723674K180189InMode System with Fractora3D/3D-90 ApplicatorsGEI2018-06-01
1435831465517591K172302InMode PLUS SystemPBX2017-12-08
1435831601841923K172193Modified 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
1435831257706801K170738InMode Diolaze XLGEX2017-08-07
16651525340707K170366Laser Peripherals, LLC Family of Bare Laser FibersGEX2017-06-08
1435831898280189K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX2017-09-18
1435831533262147K170060M22 and ResurFx SystemsGEX2017-08-09
2286021174054528K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3ILY2016-07-26
2286021477684652K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp SystemILY2016-07-05
1435832032496356K153718Spirit Hair Removal laser FamilyGEX2016-02-12
1435831414754144K153671Family of CoolGlide Aesthetic LasersGEX2016-03-09
1435831519914384K151947LightSheer Desire Light Laser SystemGEX2015-08-12
1435831170019186K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouchGEX2015-06-30
1435831212554795K142860Lumenis M22 SystemGEX2015-01-21
1435831198483633K141425ELITE + LASER SYSTEMGEX2014-09-11
1435831682711510K140732CANDELA GENTLELASE FAMILY OF LASER SYSTEMSGEX2014-11-07
1435831002937469K140122CANDELA GENTLEMAX FAMILY OF LASER SYSTEMGEX2014-05-09
1435831739902364K132431THERMAGE CPT SYSTEMGEI2013-09-06
1435832049953057K132185FAMILY OF COOLGLIDE AESTHETIC LASERSGEX2013-12-06
2286021237705992K132016LUMIX 3 PLUS AND LUMIX 3 ULTRA SYSTEMILY2014-06-02
1435831948460448K123168Q-PLUS T+ IPL LASER SYSTEMGEX2012-12-20
1435831731731226K122579VELASHAPENUV2012-09-13
1435831112509969K121346PICOSURE WORKSTATIONGEX2012-11-27
1435831505236766K120622PALOMAR VECTUS LASERGEX2012-05-23
1435831857716840K120433CLEAR + BRILLIANT LASER SYSTEMONG2012-04-02
1435831624796076K120235MODEL FAMILY OF AEROLASE ND:YAG LASERS: FRIENDLYLIGHT ND: YAG LASERS, FRIENDLYLIGHT NEO, LIGHTPOD ND: YAG LASERS, LIGHTPGEX2012-09-17
1435831052007157K120023ZELTIQ COOLSCULPTINGOOK2012-05-02
1435831590858227K113868EPLUS SKIN TREATMENT SYSTEMGEX2012-06-11
1435831443627440K113702FOTONA XP ND: YAG LASER SYSTEMPDZ2012-03-28
1435831101537128K113687EQUINOX RELIEVEBZR2012-04-30
1435831547306178K110907PALOMAR ICON (TM) AESTHETIC SYSTEMGEX2011-06-22
1435831538420261K101916JOULE MULTI-PLATFORM SYSTEMGEX2011-03-18
1044231415976523K100116LASERTOUCHONE (OTC)NUH2010-04-15
1298951314285871K091285AL T LASER, MODEL AVI HPLL-12ILY2009-07-28
1435831427679195K091169ELITE MPX LASER SYSTEM WITH CRYO CGEX2009-05-13
1435831764357807K090618CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO CGEX2009-04-14
1435831975954817K083848ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORMGEX2009-04-14
1044231757299440K083822LASER TOUCHONEGZJ2009-05-06
1298951424575049K082445CURATIVE980 DIODE LASERGEX2008-10-15
1435831755754074K072564ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORMGEX2008-05-23
1435831162816385K070388PROFILE MULTI-PLATFORM SYSTEMGEX2007-05-02
1435831053634176K063112REVLITE Q-SWITCHED ND:YAG LASERGEX2006-12-01
1435832073094018K060395CRYO, MODEL V6.0GEX2006-02-24
2286021836257953K052814LUMINA 1600, 3300 AND 6600 SYSTEMSILY2005-11-30
1435831411558947K043251CANDELA FAMILY OF PULSED DYE LASER SYSTEMS, MODELS VBEAM, CBEAM, SPTL-1BGEX2005-02-09
2286021093788581K042256IR HEAT LAMP SYSTEMS: ICL 15 HFPL SYSTEM, ICL 60 PLUS HFPL SYSTEM (MODELS 40, 100 AND 250), ICL 100 ACTIVO SCANNER SYSTEILY2004-11-17
1435831191662934K041959POLARIS DS/COMETGEX2004-11-08
1435831710306738K041930VARILITE LASER SYSTEMGEX2004-09-10
1435831865771691K033549STARLUX PULSED LIGHT SYSTEMGEX2004-03-10
1435832028751709K033172CANDELA GENTLEYAG FAMILY OF LASER SYSTEMSGEX2003-10-30
1435831630418240K031488CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASERGEX2003-06-04
16651808869809K030959BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100GEX2003-04-25
1435831072851459K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERSGEX2003-04-15
1435832008422898K024371CANDELA GENTLE LASE FAMILY OF LASER SYSTEMGEX2003-03-31
1435831240421955K023193CANDELA GENTLE YAG LASER SYSTEMGEX2002-12-20
16651819266989K011207LASER PERIPHERALS REUSABLE HOLMIUM FIBERGEX2001-07-24
1435831941786202
2532601011067807
1298951114650551
16651258681942
1435831283854106
2215391386443159
2532601866742225
16652019155456
3462642073189368

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX622023-06-01
ILY62016-07-26
GEI52021-02-25
PBX22022-08-25
DPW22020-01-10
OHV12019-09-09
KPI12018-11-14
NUV12012-09-13
OOK12012-05-02
BZR12012-04-30
ONG12012-04-02
PDZ12012-03-28
NUH12010-04-15
GZJ12009-05-06
MNO11998-08-20

NDC#

Hemmorex-HC

Laser Pharmaceuticals, LLC

hydrocortisone acetate

Hemmorex-HC

Laser Pharmaceuticals, LLC

hydrocortisone acetate

PMA#

PMN#

FlowMet

2020-01-10

Laser Associated Sciences, Inc.

FlowMet-R

2019-02-27

Laser Associated Sciences, Inc.

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next