Biolitec Medical Devices, Inc. - FDA 510(k) Cleared Devices
Recent clearances: EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL), MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM, MEGABEAM ENDO-ENT PROBE
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biolitec Medical Devices, Inc. General & Plastic Surgery ✕
9 devices
Cleared
Apr 24, 2012
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
General & Plastic Surgery
90d
Cleared
Mar 13, 2012
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
General & Plastic Surgery
89d
Cleared
Jan 24, 2012
MEGABEAM ENDO-ENT PROBE
General & Plastic Surgery
25d
Cleared
Jan 20, 2012
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
General & Plastic Surgery
32d
Cleared
Jan 19, 2012
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
General & Plastic Surgery
27d
Cleared
Dec 16, 2011
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
General & Plastic Surgery
71d
Cleared
Nov 03, 2011
ENDOVASCULAR LASER VEIN SYSTEM KIT
General & Plastic Surgery
85d
Cleared
Sep 30, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
General & Plastic Surgery
37d
Cleared
Sep 06, 2011
CERALAS 980NM DIODE LASER FAMILY
General & Plastic Surgery
25d