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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 K013216
Device Name DIODENT DENTAL LASER SYSTEM
Applicant
CONTINUUM ELECTRO-OPTICS, INC.
3150 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051
Applicant Contact RONALD KOHLHARDT
Correspondent
CONTINUUM ELECTRO-OPTICS, INC.
3150 CENTRAL EXPRESSWAY
SANTA CLARA,  CA  95051
Correspondent Contact RONALD KOHLHARDT
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/26/2001
Decision Date 02/27/2002
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
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