Biolitec, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER, CERALAS 147NM DIODE LASER SYSTEM, RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
28
Total
28
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biolitec, Inc. General & Plastic Surgery ✕
28 devices
Cleared
Jan 13, 2012
EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER
General & Plastic Surgery
183d
Cleared
Sep 20, 2011
CERALAS 147NM DIODE LASER SYSTEM
General & Plastic Surgery
46d
Cleared
Feb 24, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
General & Plastic Surgery
44d
Cleared
Dec 16, 2010
CERALAS E/ 1470NM FIBER-COUPLED DIODE LASER FAMILY
General & Plastic Surgery
84d
Cleared
Oct 27, 2010
ENDOVASCULAR LAER VEIN SYSTEM KIT
General & Plastic Surgery
131d
Cleared
Sep 15, 2010
CERALAS D/ 980NM FIBER-COUPLED DIODE LASER FAMILY, CERALAS E/ 980NM...
General & Plastic Surgery
184d
Cleared
Jun 26, 2009
CERALAS MULTIWAVELENGTH 980/1470NM DIODE LASER
General & Plastic Surgery
155d
Cleared
Jan 09, 2009
180W CERELAS D 980NM DIODE LASER, MODEL D180
General & Plastic Surgery
29d
Cleared
Dec 03, 2008
15W CERALAS D 1470NM DIODE LASER, MODEL D1470
General & Plastic Surgery
119d
Cleared
Oct 24, 2008
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980
General & Plastic Surgery
77d
Cleared
Jul 08, 2008
CERALAS D 980NM DIODE LASER, MODELS D15 AND D25
General & Plastic Surgery
90d
Cleared
Apr 18, 2008
50W CERALAS D 1950NM DIODE LASER
General & Plastic Surgery
210d