Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Biolitec, Inc. — Predicate Candidate Screening

28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

90 daysmedian FDA review time

202 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days
K112013	EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER	Biolitec, Inc.	2012-01-13	183
K112253	CERALAS 147NM DIODE LASER SYSTEM	Biolitec, Inc.	2011-09-20	46
K110080	RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM	Biolitec, Inc.	2011-02-24	44
K102755	CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY; CREALAS	Biolitec, Inc.	2010-12-16	84
K101712	ENDOVASCULAR LAER VEIN SYSTEM KIT	Biolitec, Inc.	2010-10-27	131
K100726	CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E	Biolitec, Inc.	2010-09-15	184
K090164	CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER	Biolitec, Inc.	2009-06-26	155
K083682	180W CERELAS D 980NM DIODE LASER, MODEL D180	Biolitec, Inc.	2009-01-09	29
K082225	15W CERALAS D 1470NM DIODE LASER, MODEL D1470	Biolitec, Inc.	2008-12-03	119
K082263	CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980	Biolitec, Inc.	2008-10-24	77
K081015	CERALAS D 980NM DIODE LASER, MODELS D15 AND D25	Biolitec, Inc.	2008-07-08	90
K072682	50W CERALAS D 1950NM DIODE LASER	Biolitec, Inc.	2008-04-18	210
K073063	15W CERALAS D 1470NM DIODE LASER	Biolitec, Inc.	2008-02-27	120
K072779	CERALAS D 980NM DIODE LASER, MODELS D15 AND D25	Biolitec, Inc.	2008-01-24	118
K072106	150W CERALAS D 980NM DIODE LASER	Biolitec, Inc.	2007-08-30	30
K071295	100W CERALAS D 980NM DIODE LASER	Biolitec, Inc.	2007-05-16	8
K060050	MEGABEAM SIDEFIBER FIBER OPTIC DELIVERY SYSTEM	Biolitec, Inc.	2006-01-23	17
K050824	100W CERALAS D 980 LASER SYSTEM, MODEL D100	Biolitec, Inc.	2005-08-10	132
K032864	CERALAS D 810 DIODE LASER SYSTEM, MODEL D15	Biolitec, Inc.	2004-03-19	189
K032863	CERALAS D 980 DIODE LASER SYSTEM, MODELS D15, D25, D50	Biolitec, Inc.	2004-03-19	189
K030700	CERALAS D 10-60 810NM LASER SYSTEM WITH ENDO LASER VEIN SYST	Biolitec, Inc.	2003-06-04	90
K024088	CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT,	Biolitec, Inc.	2003-01-02	22
K013691	CERALAS D DIODE LASER SYSTEM, MODEL # D50	Biolitec, Inc.	2002-08-13	279
K020835	CERALAS D10-60 810NM DIODE LASER, MODELCERALAS DIO-60	Biolitec, Inc.	2002-06-12	90
K020099	MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE	Biolitec, Inc.	2002-04-11	90
K013193	MEGA BEAM/CERALAS NONSTERILE COLLIMATING HANDPIECE	Biolitec, Inc.	2001-12-21	88
K010804	MEGABEAM/CERALAS REUSEABLE HANDPIECE AND DISPOSABLE TIPS	Biolitec, Inc.	2001-10-04	202
K010689	MEGABEAM/CERALAS NON STERILE FIBER OPTIC LASER DELIVERY SYST	Biolitec, Inc.	2001-05-18	71

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda