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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 K050165
Device Name MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100
Applicant
Cyden Limited
Technium, Kings Rd.
The Docks
Swansea, Wales,  GB SA1 8PH
Applicant Contact MICHAEL NOEL KIERNAN
Correspondent
Cyden Limited
Technium, Kings Rd.
The Docks
Swansea, Wales,  GB SA1 8PH
Correspondent Contact MICHAEL NOEL KIERNAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/25/2005
Decision Date 04/19/2005
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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