ETWO SKIN TREATMENT SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K110672
Device Name ETWO SKIN TREATMENT SYSTEM
Applicant
SYNERON, LTD.
31 haavoda st.
binyamina, 

IL

30500

Applicant Contact yoram levy
Correspondent
SYNERON, LTD.
31 haavoda st.
binyamina, 

IL

30500

Correspodent Contact yoram levy
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
OUH  
Date Received 03/09/2011
Decision Date 10/03/2011
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