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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 K100726
Device Name CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM
Applicant
Biolitec, Inc.
1349 Main Rd.
Grandville,  MA  01034
Applicant Contact HARRY HAYES
Correspondent
Biolitec, Inc.
1349 Main Rd.
Grandville,  MA  01034
Correspondent Contact HARRY HAYES
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/15/2010
Decision Date 09/15/2010
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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