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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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
Correspondent Contact yoram levy
Regulation Number878.4400
Classification Product Code
GEI  
Subsequent Product Code
OUH  
Date Received03/09/2011
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
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