FDA.reportPublic FDA data

CYNOSURE, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12229931000120578CYNOSURE, LLC1Y2026-01-015 CARLISLE RD Westford MA US 01886

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
461981606918297K983333BUFFALO FILTER VIROSAFE HRF- #VSHRFO1FYD1999-08-11
461981294127943K972072SURGITRON MODEL FFPF-EMCGEI1997-06-19
461981168108933K964176TECNO REUSABLE, ELECTROSURGICAL, BIPOLAR FORCEPSGEI1997-08-14
461981456992182K963340MEDLITE ND:YAG LASER SYSTEM: NEW DYE ACCESSORY HANDPIECEGEX1997-05-12
461981990763942K955176DENTO-SURGEEKZ1996-04-15
461981154028301K954718ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGEHEE1996-02-29
461981696164398K261570PICOSURE WORKSTATIONGEX2026-06-17
461981383907677K240396Elite iQ PRO (M122K1)GEX2024-03-08
461981331571031K233550MOSAIC 3D (Surgical Laser)ONG2024-01-02
461981980392093K223292TempSure SystemGEI2022-11-23
461981082168127K213569HOLLYWOOD SPECTRA Laser SystemGEX2022-02-04
461981155303587K212891TempSure SystemGEI2022-03-18
461982024148134K210226PicoSure WorkstationGEX2021-03-30
461981864398367K203788DermaV Laser SystemGEX2021-03-26
461981679738621K200241TempSure SystemPBX2020-03-25
461981554853309K193426Elite iQGEX2020-03-09
461981727934111K192331LaseMD LEO Laser SystemGEX2019-11-12
461981103859475K190678TempSureGEI2019-07-24
461981644908051K183566CLARITY II Laser SystemGEX2019-06-14
461981597047493K182741SculpSurePKT2019-01-03
461981591822231K182365TempSure SystemGEI2018-10-24
461981958014565K180945LUTRONIC GENIUS Radiofrequency SystemGEI2018-12-10
461981934181102K173199PicoSure WorkstationGEX2018-02-07
461981873138141K171992SculpSurePKT2017-09-26
461981848594302K171262TempSureGEI2017-09-22
461981407651145K171111SculpsurePKT2017-06-13
461981594128698K160480PicoSure WorkstationGEX2016-05-17
461981771818304K160470SculpSurePKT2016-07-21
461981631502699K150724SculpSurePKT2015-07-01
461981972728436K150587Cortex Laser SystemGEX2015-07-21
461981406563900K150230SculpSurePKT2015-05-15
461981198058795K143105Picosure WorkstationGEX2015-02-23
461981749994254K142376Palomar Icon Aesthetic SystemGEX2014-09-24
461981581335647K141511SIDELAZE800 LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440MM WAVELENGTH LASERSGEX2015-01-23
461981891768507K141425ELITE + LASER SYSTEMGEX2014-09-11
461981720935944K140719PICOSURE WORKSTATIONGEX2014-09-22
461982008407618K133364PICOSURE WORKSTATIONGEX2014-07-22
461981894245576K132949PELLEFIRMPBX2014-02-20
461981848076690K132665PELLEVE GLIDESAFE 10MM, 15MM & 20MM HANDPIECE, PELLEVE S5 - IECGEI2013-09-25
461981928470869K123407CELLULAZE LASEROYW2013-03-29
461981011650509K123366SURGITRON 4.0 DUAL RF S5-IECGEI2013-07-12
461981533696366K121346PICOSURE WORKSTATIONGEX2012-11-27
461982060457052K121162POLARIS Q-SWITCH RUBY SYSTEMGEX2012-07-18
461981530131238K121127SIDELAZE LASER BEAM DELIVERY ACCESSORY FOR CYNOSURE 1440NM WAVELENGTH LASERSGEX2012-05-13
461981521808173K120622PALOMAR VECTUS LASERGEX2012-05-23
461981290720273K113668HEALITE II SYSTEMILY2012-06-19
461981804999607K111840EMERGE FRACTIONAL LASERONG2011-11-14
461981734631288K110907PALOMAR ICON (TM) AESTHETIC SYSTEMGEX2011-06-22
461982062408294K110897CORTEX CO2 / ER:YAG LASER SYSTEMGEX2011-07-01
461981312191506K110502TRIPLEX ER. YAG / ND: YAG SYSTEMGEX2011-04-27
461981508000195K110304APEX ER. YAG / IPL SYSTEMGEX2011-04-08
461982040577393K103118REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTORGEX2010-11-19
461981833619719K102698PELLEVE GLIDESAFE NON-ABLATIVE WRINKLE TREATMENT SYSTEM MODEL PELLEVE GLIDESAFEGEI2011-01-05
461981023291887K102541CYNOSURE CELLULAZE LASEROYW2012-01-26
461981111886031K101601AFFIRM DO DIODE LASERGEX2010-09-23
461981122919902K101506LUX1540, LUX1440 & LUX2940 LASER HANDPIECESONG2010-09-01
461982073337252K101415THERACLEARGEX2010-07-08
461981225522661K100893CHEVEUX DIODE LASER SYSTEMGEX2010-06-16
461981684491769K100610LUTRONIC CORPORATION ECO2 PLUS, DENTA III AND III+ AND SP III LASER SYSTEMSONG2011-01-20
461981656329874K100270ARTISAN AESTHETIC SYSTEMGEX2010-03-29
461981860431317K100230SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230VNUV2010-04-02
461981187277624K091537CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTHGEX2009-09-03
461981337247076K091169ELITE MPX LASER SYSTEM WITH CRYO CGEX2009-05-13
461981087957364K090618CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO CGEX2009-04-14
461982046928909K090195PALOMAR LUX1540 HANDPIECEGEX2009-11-20
461981446377426K083795CYNOSURE SMARTLIPO MPX LASERGEX2009-01-21
461981779849409K083629SMOOTHSHAPESNUV2009-02-19
461981278896638K083455LIPOKIT WITH DISPOSABLE 50CC AFT SYRINGE, MODEL ZLK-100MUU2009-05-18
461981701793324K083165PALOMAR ASPIRE LASER PLATFORMGEX2009-02-13
461982032951097K081424AFFIRM CO2 AND AFFIRM CO2 HPGEX2009-03-19
461981756835104K081181SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASERGEX2008-05-05

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX1012026-06-17
GEI252022-11-23
PKT122019-01-03
ONG62024-01-02
OYW42013-03-29
NUV42010-04-02
PBX32020-03-25
MUU22009-05-18
ISA22004-01-22
EKZ21996-04-15
HEE21996-02-29
ILY12012-06-19
FYD11999-08-11

PMN#

GUDID#

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