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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser Assisted Lipolysis
510(k) Number K090754
Device Name LIPOCONTROL
Applicant
Osyris Medical
60 Ave. Halley
F59650 Villeneuve D'Asq
France,  FR F59650
Applicant Contact BLANDINE BOUVET
Correspondent
Osyris Medical
60 Ave. Halley
F59650 Villeneuve D'Asq
France,  FR F59650
Correspondent Contact BLANDINE BOUVET
Regulation Number878.4810
Classification Product Code
ORK  
Subsequent Product Code
GEX  
Date Received03/20/2009
Decision Date 01/21/2011
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
Predetermined Change
Control Plan Authorized		 No
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