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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 K013193
Device Name MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE
Applicant
BIOLITEC, INC.
515 SHAKER RD.
EAST LONGMEADOW,  MA  01028
Applicant Contact CAROL J MORELLO
Correspondent
BIOLITEC, INC.
515 SHAKER RD.
EAST LONGMEADOW,  MA  01028
Correspondent Contact CAROL J MORELLO
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/24/2001
Decision Date 12/21/2001
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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