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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 K063828
Device Name DIOMED DELTA 25
Applicant
Diomed, Ltd.
Cambridge Research Park
Bldg. 2000
Cambridge, Cambridgeshire,  GB CB5 9TE
Applicant Contact TIM PHIPPS
Correspondent
Diomed, Ltd.
Cambridge Research Park
Bldg. 2000
Cambridge, Cambridgeshire,  GB CB5 9TE
Correspondent Contact TIM PHIPPS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/26/2006
Decision Date 01/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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