Medical Device Manufacturer · US , Washington , DC

Optos Plc. - FDA 510(k) Cleared Devices

15 submissions · 15 cleared · Since 1999
15
Total
15
Cleared
0
Denied

FDA 510(k) cleared devices by Optos Plc. Ophthalmic ✕

15 devices
1-15 of 15
Cleared May 09, 2024
P200TE (A10700)
K233602 · OBO
Ophthalmic · 182d
Cleared Aug 18, 2023
P200TE (A10700)
K231673 · OBO
Ophthalmic · 71d
Cleared Jul 31, 2019
P200TxE
K190732 · OBO
Ophthalmic · 132d
Cleared Feb 28, 2018
P200TE
K173707 · OBO
Ophthalmic · 86d
Cleared Feb 08, 2017
OptosAdvance 4.0 Software
K162039 · NFJ
Ophthalmic · 201d
Cleared Jan 16, 2015
P200DTx
K142897 · MYC
Ophthalmic · 105d
Cleared Apr 11, 2014
DAYTONA ICG (P200TICG)
K134039 · MYC
Ophthalmic · 101d
Cleared Feb 22, 2013
OPTOS OCT/SLO MICROPERIMETER
K121043 · OBO
Ophthalmic · 323d
Cleared May 25, 2012
OPTOS ADVANCE
K113696 · NFJ
Ophthalmic · 161d
Cleared Aug 19, 2011
P200T
K111628 · MYC
Ophthalmic · 70d
Cleared Sep 30, 2010
P200MAAF
K102492 · MYC
Ophthalmic · 30d
Cleared Jul 15, 2010
OPTOS LIMITED PANORAMIC 200CAF
K100644 · MYC
Ophthalmic · 132d
Cleared Mar 17, 2006
PANORAMIC, MODEL 200MA
K060424 · MYC
Ophthalmic · 28d
Cleared Oct 07, 2004
PANORAMIC 200A
K042001 · HLI
Ophthalmic · 73d
Cleared Feb 03, 1999
PANORAMIC200 OPTHALMOSCOPE
K983999 · HLI
Ophthalmic · 86d
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