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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 K060516
Device Name ELLIPSE 12PL, MODEL 9ESL7228
Applicant
Danish Dermatologic Development A/S
Agern Alle 11
Hoersholm,  DK dk-2970
Applicant Contact OLE KOFOD
Correspondent
Danish Dermatologic Development A/S
Agern Alle 11
Hoersholm,  DK dk-2970
Correspondent Contact OLE KOFOD
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/27/2006
Decision Date 05/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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