Syneron Medical L T D

FDA Filings

This page includes the latest FDA filings for Syneron Medical L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

ISRAELNASDAQELOSDUNS 532685716
FDA Registration(s)
Registration Number3003772750
FEI Number3003772750
NameSYNERON MEDICAL LTD.
Owner & OperatorSyneron Medical Ltd.
Contact AddressIndustrial Zone Tavor Building P.O. Box
Illit IL-NOTA 2069200 IL
Official Correspondent
  • Tsipy - Ehrlich
  • 972-73-2442556-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressIndustrial Zone Tavor Building P.O Box 550
YOKNEAM, ILLIT, 2069200 IL
Establishment TypeManufacture Medical Device

Registration Number3004772125
FEI Number3004772125
NameSYNERON, INC.
Owner & OperatorSyneron Medical Ltd.
Contact AddressIndustrial Zone Tavor Building P.O. Box
Illit IL-NOTA 2069200 IL
Official Correspondent
  • Tsipy - Ehrlich
  • 972-73-2442556-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3 Goodyear Unit A
Irvine, CA 92618 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
SYNERON MEDICAL LTD
 SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape III AS875122020-03-31
SYNERON MEDICAL LTD
 External Handpiece 5-Pack Sterile Single-Use, CO2RE Intima 2020-02-10
SYNERON MEDICAL LTD
 Regular Internal Handpiece 5-Pack Sterile Single-Use, CO2RE Intima 2020-02-10
SYNERON MEDICAL LTD
 eTwo System 2020-02-10
SYNERON MEDICAL LTD
 Intima Sterile 2 Internal + 1 External HP, Accessories Kit 2020-02-10
SYNERON MEDICAL LTD
 Hygienic Hand Piece, external, Packaged, CO2RE Int AS90245US2019-02-07
SYNERON MEDICAL LTD
 Hygienic Hand Piece Internal, Packaged, CO2RE Inti AS89733US2019-02-07
SYNERON MEDICAL LTD
 Hand Piece, external hygienic, Packaged, CO2RE  AS902452019-02-07
SYNERON MEDICAL LTD
 Hand Piece Internal hygienic, Packaged, CO2RE  AS897332019-02-07
SYNERON MEDICAL LTD
 Internal, CO2RE Intima KT76614US2019-02-07
SYNERON MEDICAL LTD
 Hand Piece Internal hygienic, Packaged, CO2RE Inti AS897342019-02-07
SYNERON MEDICAL LTD
 Standard 2 Hand-piece packing Assy, CO2RE AS875322019-02-07
SYNERON MEDICAL LTD
 'CO2RE System, Packaged (Japan) FG70412JP2019-02-07
SYNERON MEDICAL LTD
 Intima hygienic Accessories Kit, CO2RE KT770032019-02-07
SYNERON MEDICAL LTD
 Refurbished, CO2RE System for US, Packaged FG70412USR2019-02-07
SYNERON MEDICAL LTD
 Hygienic ,Intima Accessories Kit, CO2RE KT77003US2019-02-07
SYNERON MEDICAL LTD
 CO2RE System for US, Packaged FG70412US2019-02-07
SYNERON MEDICAL LTD
 CO2RE system FG704122019-02-07
SYNERON MEDICAL LTD
 Standard Hand-piece packing Assy, CO2RE AS854212019-02-07
SYNERON MEDICAL LTD
 Hand Piece, external, Packaged, CO2RE Intima AS902422019-02-07
SYNERON MEDICAL LTD
 Hand Piece Internal, Packaged, CO2RE Intima AS897312019-02-07
SYNERON MEDICAL LTD
 F100mm Lens , CO2RE AS761122019-02-07
SYNERON MEDICAL LTD
 F127mm Lens, CO2RE AS761032019-02-07
SYNERON MEDICAL LTD
 Hand Piece, external, Packaged, CO2RE Intima AS90244US2019-02-07
SYNERON MEDICAL LTD
 Internal, CO2RE Intima AS89732US2019-02-07
SYNERON MEDICAL LTD
 Intima Accessories Kit, CO2RE KT77002US2019-02-07
SYNERON MEDICAL LTD
 Lens, Gold & Silver AS920412019-02-07
SYNERON MEDICAL LTD
 Purple swivel lens AS904112019-02-07
SYNERON, INC. [Syneron Medical Ltd.]
Cooltouch ND:YAG Laser System2018-11-15
SYNERON, INC. [Syneron Medical Ltd.]
Cooltouch Varizoom2018-11-15
SYNERON, INC. [Syneron Medical Ltd.]
CoolTouch II2018-11-15
SYNERON, INC. [Syneron Medical Ltd.]
CoolTouch VariaBreeze2018-10-31
SYNERON, INC. [Syneron Medical Ltd.]
CoolTouch VariaBreeze2018-10-31
SYNERON MEDICAL LTD
 LV applicator AS10624R2018-10-08
SYNERON MEDICAL LTD
 eLaser system AS51561R2018-10-08
SYNERON MEDICAL LTD
 LVA applicator AS41302R2018-10-08
SYNERON MEDICAL LTD
 LVA applicator FG706712018-10-08
SYNERON MEDICAL LTD
 LV applicator FG706612018-10-08
SYNERON MEDICAL LTD
 SR applicator AS00089R2018-10-08
SYNERON MEDICAL LTD
 MotifIR applicator FG707912018-10-08
SYNERON MEDICAL LTD
 eLase system FG707712018-10-08
SYNERON MEDICAL LTD
 Motif LHR applicator FG707812018-10-08
SYNERON MEDICAL LTD
 eLaser system AS515612018-10-08
SYNERON MEDICAL LTD
 LVA applicator AS413022018-10-08
SYNERON MEDICAL LTD
 LV applicator AS106242018-10-08
SYNERON MEDICAL LTD
 SR applicator AS000892018-10-08
SYNERON MEDICAL LTD.
CO2RE, CO2RE Intima2018-09-21
SYNERON MEDICAL LTD
 High Density 144 Sublative iD (20 Pulse), 10-Pk   KT731712018-07-06
SYNERON MEDICAL LTD
 Standard 64 Sublative iD, (20 Pulse), 10-Pk KT731612018-07-06
SYNERON MEDICAL LTD
 High Density 144 Sublative iD (400 Pulse), 10-Pk KT729812018-07-06
SYNERON MEDICAL LTD
 High Density 144 Sublative iD (100 Pulse), 10-Pk KT728912018-07-06
SYNERON MEDICAL LTD
 LA Repl. Stacking Covers (16 Hr) 10-Pk KT748412018-07-06
SYNERON MEDICAL LTD
 Focal 90 Sublative iD, (400 Pulse), 10-Pk KT744512018-07-06
SYNERON MEDICAL LTD
 Focal 44 Sublative iD, (20 Pulse), 10-Pk KT729722018-07-06
SYNERON MEDICAL LTD
 Standard 64 Sublative iD, (200 Pulse), 10-Pk KT729312018-07-06
SYNERON MEDICAL LTD
 High Density 144 Sublative iD (200 Pulse), 10-Pk KT729212018-07-06
SYNERON MEDICAL LTD
 SA Repl. Med. Cvr. 25x30mm (4 Hr) 10-Pk, Velashape KT7426A2018-07-06
SYNERON MEDICAL LTD
 SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 10-Pk, Vela KT756612018-07-06
SYNERON MEDICAL LTD
 SA Repl. Small Cvr. 10x13mm (4 Hr) 10-Pk, Velashap KT7425A2018-07-06
SYNERON MEDICAL LTD
 SA Repl. Cvr. (1Hr) 10-Pk, VelaShape II KT717512018-07-06
SYNERON MEDICAL LTD
 LA Repl. Cvr. (1Hr) 10-Pk KT717452018-07-06
SYNERON MEDICAL LTD
 LA Replaceable Cover (4 Hr) 5-Pk KT751022018-07-06
SYNERON MEDICAL LTD
 LA Repl. Stacking Covers (8 Hr) 5-Pk  KT748312018-07-06
SYNERON MEDICAL LTD
 SA Repl. Med. Cvr. 25x30mm (4 Hr) 5-Pk, Velashape KT750712018-07-06
SYNERON MEDICAL LTD
 SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velas KT756712018-07-06
SYNERON MEDICAL LTD
 SA Repl. Small Cvr. 10x13mm (4 Hr) 5-Pk, Velashape KT750612018-07-06
SYNERON MEDICAL LTD
 High Dens.144 Tip,Fuse (200 Puls), Steril, SubRF AS766942018-07-06
SYNERON MEDICAL LTD
 Standard 64 Tip,Fuse (200 Puls), Steril, SubRF AS748762018-07-06
SYNERON MEDICAL LTD
 eMatrix system FG704422018-07-06
SYNERON MEDICAL LTD
 Repl. Cover , SA-12Hr AS802512018-07-06
SYNERON MEDICAL LTD
 Repl. Cover LA-24Hr AS802422018-07-06
SYNERON MEDICAL LTD
 Repl. Cover, SA-4Hr AS754022018-07-06
SYNERON MEDICAL LTD
 Repl. Cover, LA-16Hr AS753942018-07-06
SYNERON MEDICAL LTD
 Velasmooth Pro, Small applicator FG702312018-07-06
SYNERON MEDICAL LTD
 Velasmooth Pro, Large applicator FG702412018-07-06
SYNERON MEDICAL LTD
 VelasmoothPro system FG702612018-07-06
SYNERON MEDICAL LTD
 VelasmoothPro system FG702712018-07-06
SYNERON MEDICAL LTD
 Vela applicator AS203562018-07-06
SYNERON MEDICAL LTD
 Velasmooth system AS203412018-07-06
SYNERON MEDICAL LTD
 Velasmooth system AS240212018-07-06
SYNERON MEDICAL LTD
 Repl. Cover (cream), SA-4Hr, VelaShape II AS778132018-07-06
SYNERON MEDICAL LTD
 SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III AS833322018-07-06
SYNERON MEDICAL LTD
 SA Flat Lrg. Repl. Cover 25x50mm, 4Hr, Velashape I AS875112018-07-06
SYNERON MEDICAL LTD
 SA Small Repl. Cover 10x13mm, 4Hr, Velashape III AS833222018-07-06
SYNERON MEDICAL LTD
 Vsmooth applicator FG711712018-07-06
SYNERON MEDICAL LTD
 Vcontour applicator FG710122018-07-06
SYNERON MEDICAL LTD
 Repl. Cover AS746722018-07-06
SYNERON MEDICAL LTD
 Repl. Cover (Grey), LA-1Hr, VelaShape II AS746862018-07-06
SYNERON MEDICAL LTD
 Vcontour Applicator FG703512018-07-06
SYNERON MEDICAL LTD
 Vsmooth Applicator FG703412018-07-06
SYNERON MEDICAL LTD
 Vela Shape II system FG703312018-07-06
SYNERON MEDICAL LTD
 Vela Shape II system FG703212018-07-06
SYNERON MEDICAL LTD
 Vcontour Applicator FG001112018-07-06
SYNERON MEDICAL LTD
 Vsmooth Applicator FG001012018-07-06
SYNERON MEDICAL LTD
 VelaShape system FG001312018-07-06
SYNERON MEDICAL LTD
 MotifHR applicator FG708812018-07-06
SYNERON MEDICAL LTD
 eLight system AS524222018-07-06
SYNERON MEDICAL LTD
 eLight system FG702822018-07-06
SYNERON MEDICAL LTD
 MatrixIR applicator FG001612018-07-06
SYNERON MEDICAL LTD
 WRA applicator AS087832018-07-06
SYNERON MEDICAL LTD
 DSL applicator AS343422018-07-06
SYNERON MEDICAL LTD
 AC applicator AS138432018-07-06
SYNERON MEDICAL LTD
 SRA applicator AS374322018-07-06
SYNERON MEDICAL LTD
 ST applicator AS452822018-07-06
SYNERON MEDICAL LTD
 DS applicator AS000992018-07-06
SYNERON MEDICAL LTD
 eMax AS108122018-07-06
SYNERON MEDICAL LTD.
UltraShape Power and accessories2017-10-27
Syneron Medical Ltd.
ULTRASHAPE POWER SYSTEM2017-05-15
Syneron Medical Ltd.
SlimShape System2017-04-20
SYNERON MEDICAL LTD.
Profound system2016-12-15
SYNERON MEDICAL LTD.
Profound system2016-12-15
SYNERON MEDICAL LTD
UltraShape System2016-11-17
Syneron Medical Ltd.
UltraShape System2016-11-07
SYNERON MEDICAL LTD
ULTRASHAPE POWER SYSTEM2016-07-08
SYNERON MEDICAL LTD.
eTwo and applicators2016-06-05
SYNERON MEDICAL LTD.
CO2RE System2015-09-15
SYNERON MEDICAL LTD.
TWO SKIN TREATMENT SYSTEM2014-12-08
SYNERON MEDICAL LTD.
ULTRASHAPE SYSTEM2014-10-06
SYNERON MEDICAL LTD
CONTOUR I V3.1 SYSTEM2014-04-10
SYNERON MEDICAL LTD.
TRANSCEND2013-07-19
SYNERON MEDICAL LTD.
Velashape system2013-07-19
SYNERON MEDICAL LTD.
ME HAIR2GO2012-10-12
SYNERON MEDICAL LTD.
VELASHAPE2012-09-13
SYNERON MEDICAL LTD.
elos Plus System2012-06-15
SYNERON MEDICAL LTD.
e Plus2012-06-15
SYNERON MEDICAL LTD.
Sublime Applicator, elos Plus2012-06-15
SYNERON MEDICAL LTD.
SRA Plus Applicator, elos Plus2012-06-15
SYNERON MEDICAL LTD.
SRA Mini Applicator, elos Plus2012-06-15
SYNERON MEDICAL LTD.
SR Applicator, elos Plus2012-06-15
SYNERON MEDICAL LTD.
Motif Vantage Applicator, elos Plus2012-06-15
SYNERON MEDICAL LTD.
Motif IR Applicator, elos plus2012-06-15
SYNERON MEDICAL LTD.
Motif HR Applicator, elos plus2012-06-15
SYNERON MEDICAL LTD.
AC Applicator, elos Plus2012-06-15
SYNERON MEDICAL LTD.
EMATRIX CO22010-11-09
SYNERON MEDICAL LTD.
MATRIX RF APPLICATOR2010-01-08
SYNERON MEDICAL LTD.
MATRIX RF APPLICATOR2008-09-17
SYNERON MEDICAL LTD.
ELIPO2008-04-23
SYNERON MEDICAL LTD.
VELASHAPE2007-08-22
SYNERON MEDICAL LTD.
MODIFICATION TO VELASMOOTH, SHAPER2007-07-27
SYNERON MEDICAL LTD.
POLARIS WR, ST APPLICATOR2006-03-14
SYNERON MEDICAL LTD.
POLARIS LV, LVA APPLICATOR2005-09-14
SYNERON MEDICAL LTD.
VELASMOOTH, SHAPER2005-06-09
SYNERON MEDICAL LTD.
AURORA DS, DS APPLICATOR2005-04-12
SYNERON MEDICAL LTD.
AURORA SR AND SRA APPLICATOR2005-03-09
SYNERON MEDICAL LTD.
POLARIS DS/COMET2004-11-08
SYNERON MEDICAL LTD.
AURORA DS2004-10-19
SYNERON MEDICAL LTD.
AC APPLICATOR, AURORA AC2004-01-27
SYNERON MEDICAL LTD.
MODIFICATION TO AURORA DS2003-12-10
SYNERON MEDICAL LTD.
POLARIS WR2003-12-01
SYNERON MEDICAL LTD.
PITANGA2003-08-19
SYNERON MEDICAL LTD.
AURORA SR2003-08-01
SYNERON MEDICAL LTD.
AURORA DS2003-08-01
SYNERON MEDICAL LTD.
AURORA SR2002-10-03
SYNERON MEDICAL LTD.
AURORA DS2002-07-09

Related Finance Registrations
SEC0001291361Syneron Medical Ltd.
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