V-IPL Optic set Extended VTL43070

GUDID 07290016746129

V-IPL Optic set Extended

VIORA LTD

Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system Intense pulsed light skin surface treatment system
Primary Device ID07290016746129
NIH Device Record Key84381d87-aac1-4edd-9bb7-727979e9fa45
Commercial Distribution StatusIn Commercial Distribution
Brand NameV-IPL Optic set Extended
Version Model NumberVTL43070
Catalog NumberVTL43070
Company DUNS514612758
Company NameVIORA LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com
Phone8884151192
EmailCustomerCareUSA@vioramed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290016746129 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

Devices Manufactured by VIORA LTD

07290016746006 - V30 Console 2018-07-06 V30 Console
07290016746013 - V20 Console2018-07-06 V20 Console
07290016746020 - V10 Console2018-07-06 V10 Console
07290016746037 - V- IPL Handpiece2018-07-06 V- IPL Handpiece
07290016746044 - V-IPL HP Basic2018-07-06 V-IPL HP Basic
07290016746051 - V-IPL HP Full2018-07-06 V-IPL HP Full
07290016746068 - V-IPL HP Extended2018-07-06 V-IPL HP Extended
07290016746075 - V-IPL Filter HR-630  2018-07-06 V-IPL Filter HR-630  

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