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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Suction, Lipoplasty For Removal
510(k) Number K980771
Device Name LYSONIX SUCTION LIPOPLASTY SYSTEM
Applicant
Lysonix, Inc.
1170 Mark Ave.
Carpinteria,  CA  93013
Applicant Contact RONALD F LAGERQUIST
Correspondent
Lysonix, Inc.
1170 Mark Ave.
Carpinteria,  CA  93013
Correspondent Contact RONALD F LAGERQUIST
Regulation Number878.5040
Classification Product Code
QPB  
Date Received02/27/1998
Decision Date 07/13/1998
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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