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Biolitec, Inc.

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K112013 EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASERGEX2012-01-13 View
510(k) K112253 CERALAS 147NM DIODE LASER SYSTEMGEX2011-09-20 View
510(k) K110080 RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEMGEX2011-02-24 View
510(k) K102755 CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS HPD MULTIWAVELENGHT 980NM/ 1470NM FIBER-COUPLED DIODE LASERGEX2010-12-16 View
510(k) K101712 ENDOVASCULAR LAER VEIN SYSTEM KITGEX2010-10-27 View
510(k) K100726 CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS HPD/ 980NMGEX2010-09-15 View
510(k) K090164 CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASERGEX2009-06-26 View
510(k) K083682 180W CERELAS D 980NM DIODE LASER, MODEL D180GEX2009-01-09 View
510(k) K082225 15W CERALAS D 1470NM DIODE LASER, MODEL D1470GEX2008-12-03 View
510(k) K082263 CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980GEX2008-10-24 View
510(k) K081015 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25GEX2008-07-08 View
510(k) K072682 50W CERALAS D 1950NM DIODE LASERGEX2008-04-18 View
510(k) K073063 15W CERALAS D 1470NM DIODE LASERGEX2008-02-27 View
510(k) K072779 CERALAS D 980NM DIODE LASER, MODELS D15 AND D25GEX2008-01-24 View
510(k) K072106 150W CERALAS D 980NM DIODE LASERGEX2007-08-30 View
510(k) K071295 100W CERALAS D 980NM DIODE LASERGEX2007-05-16 View
510(k) K060050 MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEMGEX2006-01-23 View
510(k) K050824 100W CERALAS D 980 LASER SYSTEM, MODEL D100GEX2005-08-10 View
510(k) K032863 CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50GEX2004-03-19 View
510(k) K032864 CERALAS D 810 DIODE LASER SYSTEM, MODEL D15GEX2004-03-19 View
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