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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