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Biolitec Medical Devices, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K120231EVOLVE HPD 980/ 1470NM MULTIWAVELENGTH DIODE LASER (EVOLVE DUAL)April 24, 2012
K113688MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEMMarch 13, 2012
K113858MEGABEAM ENDO-ENT PROBEJanuary 24, 2012
K113709MEGABEAM FIBER OPTIC DELIVERY SYSTEM WITH ADDITIONAL TIPS & HANDPIECEJanuary 20, 2012
K113792MEGABEAM ENDOCULAR PROBE AND ASPIRATING ENDOCULAR PROBEJanuary 19, 2012
K112987TWISTER SIDE FIRE OPTICAL FIBER DELIVERY SYSTEMDecember 16, 2011
K112299ENDOVASCULAR LASER VEIN SYSTEM KITNovember 3, 2011
K112442RADIAL-EMITTING SHAPED FIBER OPTIC DELIVERY SYSTEMSeptember 30, 2011
K112324CERALAS 980NM DIODE LASER FAMILYSeptember 6, 2011