Medical Device Manufacturer · US , Grandville , MA

Biolitec Medical Devices, Inc. - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2011
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Biolitec Medical Devices, Inc. General & Plastic Surgery ✕
9 devices
1-9 of 9
Cleared Apr 24, 2012
EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)
K120231 · GEX
General & Plastic Surgery · 90d
Cleared Mar 13, 2012
MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM
K113688 · GEX
General & Plastic Surgery · 89d
Cleared Jan 24, 2012
MEGABEAM ENDO-ENT PROBE
K113858 · GEX
General & Plastic Surgery · 25d
Cleared Jan 20, 2012
MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECE
K113709 · GEX
General & Plastic Surgery · 32d
Cleared Jan 19, 2012
MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBE
K113792 · GEX
General & Plastic Surgery · 27d
Cleared Dec 16, 2011
TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEM
K112987 · GEX
General & Plastic Surgery · 71d
Cleared Nov 03, 2011
ENDOVASCULAR LASER VEIN SYSTEM KIT
K112299 · GEX
General & Plastic Surgery · 85d
Cleared Sep 30, 2011
RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEM
K112442 · GEX
General & Plastic Surgery · 37d
Cleared Sep 06, 2011
CERALAS 980NM DIODE LASER FAMILY
K112324 · GEX
General & Plastic Surgery · 25d
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