FDA 510(k) Applications Submitted by BIOLITEC, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K020099 01/11/2002 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC.
K010689 03/08/2001 MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYSTEMS, MODEL 200,320,400 OR 600UM BIOLITEC, INC.
K010804 03/16/2001 MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS BIOLITEC, INC.
K013193 09/24/2001 MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE BIOLITEC, INC.
K100726 03/15/2010 CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NM BIOLITEC, INC.
K101712 06/18/2010 ENDOVASCULAR LAER VEIN SYSTEM KIT BIOLITEC, INC.
K112013 07/14/2011 EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER BIOLITEC, INC.
K112253 08/05/2011 CERALAS 147NM DIODE LASER SYSTEM BIOLITEC, INC.
K060050 01/06/2006 MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM BIOLITEC, INC.
K090164 01/22/2009 CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER BIOLITEC, INC.
K030700 03/06/2003 CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT BIOLITEC, INC.
K020835 03/14/2002 CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60 BIOLITEC, INC.
K050824 03/31/2005 100W CERALAS D 980 LASER SYSTEM, MODEL D100 BIOLITEC, INC.
K081015 04/09/2008 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC.
K071295 05/08/2007 100W CERALAS D 980NM DIODE LASER BIOLITEC, INC.
K072106 07/31/2007 150W CERALAS D 980NM DIODE LASER BIOLITEC, INC.
K082225 08/06/2008 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 BIOLITEC, INC.
K082263 08/08/2008 CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 BIOLITEC, INC.
K032863 09/12/2003 CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50 BIOLITEC, INC.
K072682 09/21/2007 50W CERALAS D 1950NM DIODE LASER BIOLITEC, INC.
K072779 09/28/2007 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25 BIOLITEC, INC.
K073063 10/30/2007 15W CERALAS D 1470NM DIODE LASER BIOLITEC, INC.
K013691 11/07/2001 CERALAS D DIODE LASER SYSTEM, MODEL # D50 BIOLITEC, INC.
K024088 12/11/2002 CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25 BIOLITEC, INC.
K083682 12/11/2008 180W CERELAS D 980NM DIODE LASER, MODEL D180 BIOLITEC, INC.
K032864 09/12/2003 CERALAS D 810 DIODE LASER SYSTEM, MODEL D15 BIOLITEC, INC.
K110080 01/11/2011 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM BIOLITEC, INC.
K102755 09/23/2010 CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASER BIOLITEC, INC.


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