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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 K111689
Device Name STLASE
Applicant
Dental Photonics, Inc.
131 Kelekent Lane
Cary,  NC  27518
Applicant Contact Marcy Moore
Correspondent
Dental Photonics, Inc.
131 Kelekent Lane
Cary,  NC  27518
Correspondent Contact Marcy Moore
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/16/2011
Decision Date 02/16/2012
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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