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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 K022351
Device Name DIODENT DENTAL LASER SYSTEM
Applicant
Continuum Electro-Optics, Inc.
3150 Central Expy.
Santa Clara,  CA  95051
Applicant Contact THOMAS J HANEY
Correspondent
Continuum Electro-Optics, Inc.
3150 Central Expy.
Santa Clara,  CA  95051
Correspondent Contact THOMAS J HANEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/19/2002
Decision Date 10/16/2002
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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