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Optimedica Corporation

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1683-2015Class IICatalys Precision Laser System-Catalys - U - US product; Catalys-1 - International product; softwareFebruary 20, 2015
Z-0649-2014Class IICatalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (InternaDecember 20, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K161455Catalys Precision Laser SystemSeptember 20, 2016
K141079OPTIMEDICA CATALYS PRECISION LASER SYSTEMSeptember 11, 2014
K121091CATALYS PRECISION LASER SYSTEMAugust 28, 2012
K113479OPTIMEDICA CATALYS PRECISION LASER SYSTEMDecember 21, 2011
K100019PASCAL STREAMLINE PHOTOCOAGULATORMay 4, 2010
K091666PASCAL PHOTOCOAGULATOR, PASCAL-USJuly 15, 2009
K081744PASCAL SYNTHESIS DELIVERY SYSTEMSeptember 9, 2008
K062336OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPEOctober 19, 2006