510(k) K112334

Device: VEIN-GOGH INSTRUMENT
Applicant: REFINE USA, LLC
510(k) number: K112334
Product code: ONQ
Decision: Substantially Equivalent (SESE)
Decision date: 2012-05-08
Date received: 2011-08-12
Regulation: 878.4400
Classification name: Electrosurgical Coagulation For Aesthetic
Medical specialty: General & Plastic Surgery
Review panel: General & Plastic Surgery
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: BRIAN SMITH
Address: 340 3rd Ave. S. Suite C Jacksonville Beach FL US 32250 32250

FDA Registration Numbers#

3008816935
3008264458
3005941719
3010709436
3010363436

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
86573000021011	VeinGogh	AP MEDESTHETICS, INC.	2016-12-22

Other 510(k) Records For Product Code ONQ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K210077	MED RF 4000	F Care Systems USA, LLC	2021-12-17
K130283	EVRF SYSTEM	F Care Systems NV	2013-03-07
K083352	VEINWAVE, TC3000	Newlands Clinical Trials, Ltd.	2009-06-12

Legacy Summary#

summary

FDA Review#

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