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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 K140670
Device Name ELLIPSE I2PL+/ELLIPSE MULTIFLEX+
Applicant
Ellipse A/S
Agern Alle 11
Hoersholm,  DK dk-2970
Applicant Contact OLE KOFOD
Correspondent
Ellipse A/S
Agern Alle 11
Hoersholm,  DK dk-2970
Correspondent Contact OLE KOFOD
Regulation Number878.4810
Classification Product Code
ONF  
Subsequent Product Code
GEX  
Date Received03/18/2014
Decision Date 09/25/2014
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
Recalls CDRH Recalls
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