Data / Medical devices / Israel / Viora Ltd.

Viora Ltd.: FDA-registered device maker in Migdal HaEmek Northern, Israel, 11 510(k) clearances

Name: Viora Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Viora Ltd. is registered with the FDA (registration 3005695724) in Migdal HaEmek Northern, Israel. It lists 9 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 9, 2020. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3005695724
Address: Sagi 2000 Industrial Park, Migdal HaEmek Northern, Israel, 1812003
Owner or operator: VIORA LTD. (9086237)
Roles: Complaint file establishment, Exporter to the US, Manufacturer
First device listed: April 25, 2006
Registered through: 2027
Brand names listed: Brush Single-Use Tip, Dermafuse, Flat Single-Use Tip, Pristine, Reaction System, Trios System, V10 System and V20 System with V-FORM Handpiece with BC Small,Medium and Large Applicators, V10 System with V-ST Handpiece and V-FORM Handpiece with BC and FC Applicators and more

Devices it lists

Device	Product code	Class	Role	Source
Dermatome	GFD	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Injector, Fluid, Non-Electrically Powered	KZE	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Massager, Vacuum, Light Induced Heating	NUV	2	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Complaint file establishment, Exporter to the US, Manufacturer	accessdata.fda.gov
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	ONF	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 9, 2020	K202247	V30 system, V20 system, V10 system, V-VR Hand piece	PBX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
July 15, 2020	K201064	V30 System, V20 System, V10 System, V-FR Handpiece	PBX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
May 21, 2020	K200468	V30 system, V20 system, V10 system, V-FC Handpiece	PBX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
November 18, 2016	K162363	V30 system, V-Form Handpiece BC Medium applicator	GEX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
February 19, 2016	K152611	V20 system	GEX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
May 1, 2015	K150035	V10 system	PBX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
November 14, 2014	K142093	V20 SYSTEM	GEX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
April 9, 2014	K133837	VIORA V-TOTAL	GEX	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
July 1, 2009	K090221	REACTION SYSTEM	NUV	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
June 10, 2009	K090399	TRIOS SYSTEM	ONF	Substantially Equivalent	Viora , Ltd.	accessdata.fda.gov
January 23, 2009	K082138	AIRGENT, MODEL AG7000010	KZE	Substantially Equivalent	Perfaction, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 9, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.