ClearanceBrief
Company ยท US

Optos Plc.

FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2024. Name variants (Inc, Corp, punctuation) are merged.

15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
MYCOphthalmoscope, Laser, Scanning6
OBOTomography, Optical Coherence5
HLIOphthalmoscope, Ac-Powered2
NFJSystem, Image Management, Ophthalmic2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 9, 2024K233602P200TE (A10700)
Optos Plc., GB
OBO
Aug 18, 2023K231673P200TE (A10700)
Optos Plc., GB
OBO
Jul 31, 2019K190732P200TxE
Optos Plc., GB
OBO
Feb 28, 2018K173707P200TE
Optos Plc., GB
OBO
Feb 8, 2017K162039OptosAdvance 4.0 Software
Optos Plc., GB
NFJ
Jan 16, 2015K142897P200DTx
Optos Plc., GB
MYC
Apr 11, 2014K134039DAYTONA ICG (P200TICG)
Optos Plc.
MYC
Feb 22, 2013K121043OPTOS OCT/SLO MICROPERIMETER
Optos Plc.
OBO
May 25, 2012K113696OPTOS ADVANCE
Optos Plc.
NFJ
Aug 19, 2011K111628P200T
Optos Plc.
MYC
Sep 30, 2010K102492P200MAAF
Optos Plc.
MYC
Jul 15, 2010K100644OPTOS LIMITED PANORAMIC 200CAF
Optos Plc.
MYC
Mar 17, 2006K060424PANORAMIC, MODEL 200MA
Optos Plc.
MYC
Oct 7, 2004K042001PANORAMIC 200A
Optos Plc.
HLI
Feb 3, 1999K983999PANORAMIC200 OPTHALMOSCOPE
Optos Plc.
HLI

Latest recalls

DateFirm and productCodeLinked 510(k)
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