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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered light based non-laser surgical instrument with thermal effect
510(k) Number K143339
Device Name Mini me
Applicant
ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.)
KOCHAV YOKNEAM BLDG. YOKNEAM INDUSTRIAL ZONE
YOKNEAM ILLIT,  IL 20692
Applicant Contact BOBAE KIM
Correspondent
HOGAN LOVELLS US LLP
1835 MARKET ST., 29TH FL
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number878.4810
Classification Product Code
ONF  
Date Received11/20/2014
Decision Date 12/19/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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