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FDA 510(k) Applications Submitted by Ruthie Amir, MD
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230019
01/03/2023
SofWave System
Sofwave Medical Ltd.
K170370
02/06/2017
ULTRASHAPE POWER SYSTEM
Syneron Medical Ltd.
K150326
02/09/2015
PicoWay Laser System
Candela Corporation
K170597
02/28/2017
PicoWay Laser System
Syneron Candela Corporation
K160607
03/02/2016
PicoWay Laser System
SYNERON CANDELA CORPORATION
K230820
03/24/2023
SofWave System
Sofwave Medical Ltd
K160896
03/31/2016
ULTRASHAPE POWER SYSTEM
SYNERON MEDICAL LTD
K161043
04/13/2016
Profound System
SYNERON CANDELA CORPORATION
K211483
05/12/2021
SofWave System
Sofwave Medical Ltd.
K191421
05/28/2019
Sofacia System
Sofwave Medical Ltd.
K151655
06/18/2015
CO2RE System
SYNERON MEDICAL LTD.
K161952
07/15/2016
UltraShape System
Syneron Medical Ltd.
K162163
08/02/2016
UltraShape System
SYNERON MEDICAL LTD
K142372
08/25/2014
Pico Way Laser System
CANDELA CORPATION
K162454
09/01/2016
PicoWay Laser System
SYNERON CANDELA CORPORATION
K223237
10/19/2022
SofWave System
Sofwave Medical Ltd.
K163415
12/05/2016
SlimShape System
Syneron Medical Ltd.
K153527
12/09/2015
PicoWay Laser System
SYNERON CANDELA CORPORATION
K231537
05/30/2023
SofWave System
Sofwave Medical Ltd.
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