Alcon LenSx, Inc.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
2
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1445-2014Class IIAlcon LenSx Ophthalmic Laser, for use in cataract surgery for the creation of corneal cuts/incisionMarch 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K123120LENSX LASER SYSTEMDecember 12, 2012
K120732LENSSX LASER SYSTEMSeptember 6, 2012