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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 K063384
Device Name DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
Applicant
Hoya Conbio, Inc.
19722 Westview Dr.
Twain Harte,  CA  95383
Applicant Contact LIZA BURNS
Correspondent
Hoya Conbio, Inc.
19722 Westview Dr.
Twain Harte,  CA  95383
Correspondent Contact LIZA BURNS
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/08/2006
Decision Date 03/16/2007
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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