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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 K013461
Device Name NLITE SYSTEM,MODEL A00-1025
Applicant
Icn Photonics , Ltd.
Units 1&2 Heol Rhosyn,
Dafen Park
Llanelli,  GB SA148QG
Applicant Contact MIKE KIERMAN
Correspondent
Icn Photonics , Ltd.
Units 1&2 Heol Rhosyn,
Dafen Park
Llanelli,  GB SA148QG
Correspondent Contact MIKE KIERMAN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/18/2001
Decision Date 01/17/2002
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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