Medical Device Manufacturer · IL , Yokneam Elite

Syneron Medical, Ltd. - FDA 510(k) Cleared Devices

35 submissions · 35 cleared · Since 2002

Recent clearances: ULTRASHAPE POWER SYSTEM, SlimShape System, UltraShape System

35
Total
35
Cleared
0
Denied

FDA 510(k) Regulatory Record - Syneron Medical, Ltd. General & Plastic Surgery ✕

35 devices
1-12 of 35
Cleared CT May 15, 2017
ULTRASHAPE POWER SYSTEM
K170370 · OHV
General & Plastic Surgery · 98d
Cleared CT Apr 20, 2017
SlimShape System
K163415 · GEI
General & Plastic Surgery · 136d
Cleared CT Nov 17, 2016
UltraShape System
K162163 · OHV
General & Plastic Surgery · 107d
Cleared CT Nov 07, 2016
UltraShape System
K161952 · OHV
General & Plastic Surgery · 115d
Cleared CT Jul 08, 2016
ULTRASHAPE POWER SYSTEM
K160896 · OHV
General & Plastic Surgery · 99d
Cleared Sep 15, 2015
CO2RE System
K151655 · GEX
General & Plastic Surgery · 89d
Cleared Dec 08, 2014
TWO SKIN TREATMENT SYSTEM
K141507 · GEI
General & Plastic Surgery · 185d
Cleared CT Oct 06, 2014
ULTRASHAPE SYSTEM
K141708 · OHV
General & Plastic Surgery · 104d
Cleared Apr 10, 2014
CONTOUR I V3.1 SYSTEM
K133238 · OHV
General & Plastic Surgery · 171d
Cleared Jul 19, 2013
TRANSCEND
K120510 · GEI
General & Plastic Surgery · 514d
Cleared Oct 12, 2012
ME HAIR2GO
K121598 · ONF
General & Plastic Surgery · 134d
Cleared Sep 13, 2012
VELASHAPE
K122579 · NUV
General & Plastic Surgery · 21d
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