VENUS SWAN SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K111784
Device Name VENUS SWAN SYSTEM
Applicant
VENUS CONCEPT LTD
31 haavoda st
binyamina, 

IL

30500

Applicant Contact yoram levy
Correspondent
VENUS CONCEPT LTD
31 haavoda st
binyamina, 

IL

30500

Correspodent Contact yoram levy
Regulation Number 878.4400
Classification Product Code
GEI  
Date Received 06/21/2011
Decision Date 10/07/2011
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