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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 K102755
Device Name CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER
Applicant
Biolitec, Inc.
515 Shaker Rd.
East Longmeadow,  MA  01028
Applicant Contact NANCY FOLEY
Correspondent
Biolitec, Inc.
515 Shaker Rd.
East Longmeadow,  MA  01028
Correspondent Contact NANCY FOLEY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/23/2010
Decision Date 12/16/2010
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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