VEIN-GOGH INSTRUMENT


Device Classification Name

electrosurgical coagulation for aesthetic

510(k) Number K112334
Device Name VEIN-GOGH INSTRUMENT
Applicant
REFINE USA, LLC
340 3rd avenue south
suite c
jacksonville beach, 
FL 
32250

Applicant Contact brian smith
Correspondent
REFINE USA, LLC
340 3rd avenue south
suite c
jacksonville beach, 
FL 
32250

Correspodent Contact brian smith
Regulation Number 878.4400
Classification Product Code
ONQ  
Date Received 08/12/2011
Decision Date 05/08/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No