ClearanceBrief
Company ยท IL

Syneron Medical, Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2017. Name variants (Inc, Corp, punctuation) are merged.

35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEXPowered Laser Surgical Instrument20
OHVFocused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption6
GEIElectrosurgical, Cutting & Coagulation & Accessories4
NUVMassager, Vacuum, Light Induced Heating4
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 15, 2017K170370ULTRASHAPE POWER SYSTEM
Syneron Medical, Ltd., IL
OHV
Apr 20, 2017K163415SlimShape System
Syneron Medical, Ltd., IL
GEI
Nov 17, 2016K162163UltraShape System
Syneron Medical, Ltd., IL
OHV
Nov 7, 2016K161952UltraShape System
Syneron Medical, Ltd., IL
OHV
Jul 8, 2016K160896ULTRASHAPE POWER SYSTEM
Syneron Medical, Ltd., IL
OHV
Sep 15, 2015K151655CO2RE System
Syneron Medical, Ltd., IL
GEX
Dec 8, 2014K141507TWO SKIN TREATMENT SYSTEM
Syneron Medical, Ltd.
GEI
Oct 6, 2014K141708ULTRASHAPE SYSTEM
Syneron Medical, Ltd.
OHV
Apr 10, 2014K133238CONTOUR I V3.1 SYSTEM
Syneron Medical, Ltd.
OHV
Jul 19, 2013K120510TRANSCEND
Syneron Medical, Ltd., IL
GEI
Oct 12, 2012K121598ME HAIR2GO
Syneron Medical, Ltd.
ONF
Sep 13, 2012K122579VELASHAPE
Syneron Medical, Ltd., IL
NUV
Nov 9, 2010K101321EMATRIX CO2
Syneron Medical, Ltd., IL
GEX
Jan 8, 2010K090025MATRIX RF APPLICATOR
Syneron Medical, Ltd., IL
GEI
Sep 17, 2008K073572MATRIX RF APPLICATOR
Syneron Medical, Ltd., IL
GEX
Apr 23, 2008K073715ELIPO
Syneron Medical, Ltd., IL
GEX
Aug 22, 2007K071872VELASHAPE
Syneron Medical, Ltd., IL
NUV
Jul 27, 2007K070092MODIFICATION TO VELASMOOTH, SHAPER
Syneron Medical, Ltd., IL
NUV
Mar 14, 2006K053616POLARIS WR, ST APPLICATOR
Syneron Medical, Ltd., IL
GEX
Sep 14, 2005K052324POLARIS LV, LVA APPLICATOR
Syneron Medical, Ltd., IL
GEX
Jun 9, 2005K050397VELASMOOTH, SHAPER
Syneron Medical, Ltd.
NUV
Apr 12, 2005K050796AURORA DS, DS APPLICATOR
Syneron Medical, Ltd., IL
GEX
Mar 9, 2005K050452AURORA SR AND SRA APPLICATOR
Syneron Medical, Ltd., IL
GEX
Nov 8, 2004K041959POLARIS DS/COMET
Syneron Medical, Ltd., IL
GEX
Oct 19, 2004K041969AURORA DS
Syneron Medical, Ltd., IL
GEX
Jan 27, 2004K032514AC APPLICATOR, AURORA AC
Syneron Medical, Ltd., IL
GEX
Dec 10, 2003K033586MODIFICATION TO AURORA DS
Syneron Medical, Ltd., IL
GEX
Dec 1, 2003K031671POLARIS WR
Syneron Medical, Ltd., IL
GEX
Aug 19, 2003K031489PITANGA
Syneron Medical, Ltd., IL
GEX
Aug 1, 2003K031993AURORA SR
Syneron Medical, Ltd., IL
GEX
Aug 1, 2003K031988AURORA DS
Syneron Medical, Ltd., IL
GEX
Apr 14, 2003K030186POLRIS LV
Syneron Medical, Ltd., IL
GEX
Feb 10, 2003K024064POLARIS DS
Syneron Medical, Ltd., IL
GEX
Oct 3, 2002K022266AURORA SR
Syneron Medical, Ltd., IL
GEX
Jul 9, 2002K021149AURORA DS
Syneron Medical, Ltd., IL
GEX

Latest recalls

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