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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 K161185
Device Name LUCERNA Dental Laser
Applicant
Viax Dental Lab
Calle Potrerillos,
Flexipark Bodegas D2
Alajuela,  CR 20108
Applicant Contact EDWIN M. FIRST
Correspondent
Viax Dental Lab
Calle Potrerillos,
Flexipark Bodegas D2
Alajuela,  CR 20108
Correspondent Contact EDWIN M. FIRST
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/27/2016
Decision Date 09/26/2016
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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