Medical Device Manufacturer · US , Jersey City , NJ

Viora , Ltd. - FDA 510(k) Cleared Devices

11 submissions · 11 cleared · Since 2009

Recent clearances: V30 system, V20 system, V10 system, V-VR Hand piece, V30 System, V20 System, V10 System, V-FR Handpiece, V30 system, V20 system, V10 system, V-FC Handpiece

11
Total
11
Cleared
0
Denied

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

11 devices
1-11 of 11
Cleared Dec 09, 2020
V30 system, V20 system, V10 system, V-VR Hand piece
K202247 · PBX
General & Plastic Surgery · 121d
Cleared Jul 15, 2020
V30 System, V20 System, V10 System, V-FR Handpiece
K201064 · PBX
General & Plastic Surgery · 85d
Cleared May 21, 2020
V30 system, V20 system, V10 system, V-FC Handpiece
K200468 · PBX
General & Plastic Surgery · 85d
Cleared Nov 18, 2016
V30 system, V-Form Handpiece BC Medium applicator
K162363 · GEX
General & Plastic Surgery · 87d
Cleared Feb 19, 2016
V20 system
K152611 · GEX
General & Plastic Surgery · 158d
Cleared May 01, 2015
V10 system
K150035 · PBX
General & Plastic Surgery · 112d
Cleared Nov 14, 2014
V20 SYSTEM
K142093 · GEX
General & Plastic Surgery · 105d
Cleared Oct 21, 2014
VIORA V-TOUCH
K141904 · GEI
General & Plastic Surgery · 99d
Cleared Apr 09, 2014
VIORA V-TOTAL
K133837 · GEX
General & Plastic Surgery · 112d
Cleared Jul 01, 2009
REACTION SYSTEM
K090221 · NUV
General & Plastic Surgery · 152d
Cleared Jun 10, 2009
TRIOS SYSTEM
K090399 · ONF
General & Plastic Surgery · 113d
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