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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 K080406
Device Name IPULSE, MODEL I400
Applicant
Cyden Limited
Technium, Kings Rd.
The Docks
Swansea, Wales,  GB SA1 8PH
Applicant Contact MICHEAL KIERNAN
Correspondent
Cyden Limited
Technium, Kings Rd.
The Docks
Swansea, Wales,  GB SA1 8PH
Correspondent Contact MICHEAL KIERNAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/14/2008
Decision Date 03/10/2008
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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