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Optos Plc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
15
Inspections
5
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K233602P200TE (A10700)May 9, 2024
K231673P200TE (A10700)August 18, 2023
K190732P200TxEJuly 31, 2019
K173707P200TEFebruary 28, 2018
K162039OptosAdvance 4.0 SoftwareFebruary 8, 2017
K142897P200DTxJanuary 16, 2015
K134039DAYTONA ICG (P200TICG)April 11, 2014
K121043OPTOS OCT/SLO MICROPERIMETERFebruary 22, 2013
K113696OPTOS ADVANCEMay 25, 2012
K111628P200TAugust 19, 2011
K102492P200MAAFSeptember 30, 2010
K100644OPTOS LIMITED PANORAMIC 200CAFJuly 15, 2010
K060424PANORAMIC, MODEL 200MAMarch 17, 2006
K042001PANORAMIC 200AOctober 7, 2004
K983999PANORAMIC200 OPTHALMOSCOPEFebruary 3, 1999