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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 K983654
Device Name CYBER-LASE 2000 CURING AND WHITENING LASER
Applicant
Ics of North America, Inc.
10054 Mesa Ridge Ct.
San Diego,  CA  92121
Applicant Contact ALAN A CREAMER
Correspondent
Ics of North America, Inc.
10054 Mesa Ridge Ct.
San Diego,  CA  92121
Correspondent Contact ALAN A CREAMER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/19/1998
Decision Date 01/12/1999
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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