Optos P L C

FDA Filings

This page includes the latest FDA filings for Optos P L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005744933
FEI Number3005744933
NameOptos Inc.
Owner & OperatorOPTOS PLC
Contact AddressQUEENSFERRY HOUSE, CARNEGIE BUSINESS CAMPUS
DUNFERMLINE, FIFE GB-NOTA KY11 8GR GB
Official Correspondent
  • Alan K Leitch
  • 44-138-3843300-x
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address155 Northboro Rd Ste 12
Southborough, MA 01772 US
Establishment TypeManufacture Medical Device

Registration Number9617167
FEI Number3003060634
NameAndrew Whitlingum
Owner & OperatorOPTOS PLC
Contact AddressQUEENSFERRY HOUSE, CARNEGIE BUSINESS CAMPUS
DUNFERMLINE, FIFE GB-NOTA KY11 8GR GB
Official Correspondent
  • Alan K Leitch
  • 44-138-3843300-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address500 Nickerson Road Suite 201
Marlborough, MA 01752 US
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Andrew Whitlingum [OPTOS PLC]
P200TxE2019-08-19
Andrew Whitlingum [OPTOS PLC]
P200TxE2019-08-19
Optos Plc
P200TxE2019-07-31
Andrew Whitlingum [OPTOS PLC]
P200TE2018-03-19
Andrew Whitlingum [OPTOS PLC]
P200TE2018-03-19
Optos Plc
P200TE2018-02-28
Andrew Whitlingum [OPTOS PLC]
Optos Advance 4.02017-02-10
Optos Plc
OptosAdvance 4.0 Software2017-02-08
Optos Inc. [OPTOS PLC]
California2015-02-11
Andrew Whitlingum [OPTOS PLC]
California2015-02-11
OPTOS PLC.
P200DTx2015-01-16
OPTOS PLC
DAYTONA ICG (P200TICG)2014-04-11
OPTOS PLC
OPTOS OCT/SLO MICROPERIMETER2013-02-22
Andrew Whitlingum [OPTOS PLC]
Optos Advance2012-08-09
OPTOS PLC
OPTOS ADVANCE2012-05-25
Andrew Whitlingum [OPTOS PLC]
Daytona table2012-05-09
Optos Inc. [OPTOS PLC]
OTI-Scan 30002011-10-12
Optos Inc. [OPTOS PLC]
OTI-Scan 30002011-10-12
Optos Inc. [OPTOS PLC]
Optos SPECTRAL OCT/SLO2011-10-12
Optos Inc. [OPTOS PLC]
Panoramic P200T (Daytona)2011-10-08
Optos Inc. [OPTOS PLC]
Panoramic 200T2011-10-08
Optos Inc. [OPTOS PLC]
Daytona2011-10-08
Andrew Whitlingum [OPTOS PLC]
Panoramic P200T (Daytona)2011-10-08
Andrew Whitlingum [OPTOS PLC]
Panoramic 200T2011-10-08
Andrew Whitlingum [OPTOS PLC]
Daytona2011-10-08
OPTOS PLC
P200T2011-08-19
Optos Inc. [OPTOS PLC]
Panoramic 200MAAF2010-11-03
Optos Inc. [OPTOS PLC]
200Tx2010-11-03
Andrew Whitlingum [OPTOS PLC]
Panoramic 200MAAF2010-11-03
Andrew Whitlingum [OPTOS PLC]
200Tx2010-11-03
OPTOS PLC
P200MAAF2010-09-30
OPTOS PLC
OPTOS LIMITED PANORAMIC 200CAF2010-07-15
Optos Inc. [OPTOS PLC]
PANORAMIC2006-12-19
Optos Inc. [OPTOS PLC]
P2002006-12-19
Optos Inc. [OPTOS PLC]
200Dx2006-12-19
Andrew Whitlingum [OPTOS PLC]
PANORAMIC2006-12-19
Andrew Whitlingum [OPTOS PLC]
P2002006-12-19
Andrew Whitlingum [OPTOS PLC]
200Dx2006-12-19
Optos Inc. [OPTOS PLC]
Panoramic 200MA2006-12-19
Andrew Whitlingum [OPTOS PLC]
Panoramic 200MA2006-12-19
OPTOS PLC
PANORAMIC, MODEL 200MA2006-03-17
OPTOS PLC
PANORAMIC 200A2004-10-07
OPTOS PLC
PANORAMIC200 OPTHALMOSCOPE1999-02-03

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