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Syneron Medical, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K170370ULTRASHAPE POWER SYSTEMMay 15, 2017
K163415SlimShape SystemApril 20, 2017
K162163UltraShape SystemNovember 17, 2016
K161952UltraShape SystemNovember 7, 2016
K160896ULTRASHAPE POWER SYSTEMJuly 8, 2016
K151655CO2RE SystemSeptember 15, 2015
K141507TWO SKIN TREATMENT SYSTEMDecember 8, 2014
K141708ULTRASHAPE SYSTEMOctober 6, 2014
K133238CONTOUR I V3.1 SYSTEMApril 10, 2014
K120510TRANSCENDJuly 19, 2013
K121598ME HAIR2GOOctober 12, 2012
K122579VELASHAPESeptember 13, 2012
K101321EMATRIX CO2November 9, 2010
K090025MATRIX RF APPLICATORJanuary 8, 2010
K073572MATRIX RF APPLICATORSeptember 17, 2008
K073715ELIPOApril 23, 2008
K071872VELASHAPEAugust 22, 2007
K070092MODIFICATION TO VELASMOOTH, SHAPERJuly 27, 2007
K053616POLARIS WR, ST APPLICATORMarch 14, 2006
K052324POLARIS LV, LVA APPLICATORSeptember 14, 2005