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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K091800
Device Name LIPOEZE LASER ASSISTED ASPIRATION CANNULA
Applicant
Curve Medical
200 Homer Ave.
Ashland,  MA  01721
Applicant Contact F. DAVID ROTHKOPF
Correspondent
Curve Medical
200 Homer Ave.
Ashland,  MA  01721
Correspondent Contact F. DAVID ROTHKOPF
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/17/2009
Decision Date 09/23/2009
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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