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American Optisurgical Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1505-2013Class IIFAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.April 30, 2013
Z-1518-2013Class IITX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System isApril 30, 2013
Z-1516-2013Class IIAmerican Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is inMarch 30, 2013
Z-1817-2012Class IITX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator February 22, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K101561TX1 TISSUE REMOVAL SYSTEMAugust 27, 2010
K080803VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551September 22, 2008
K020527HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030July 9, 2002
K953539DM001 DISPOSABLE PACKDecember 26, 1995
K953538RM001 REUSABLEDecember 26, 1995
K952331AOI LC-40 PHACOEMULSIFIERAugust 16, 1995