Data / Medical devices / United Kingdom / Optos Plc

Optos Plc: FDA-registered device maker in Dunfermline, Fife, United Kingdom, 10 510(k) clearances

Name: Optos Plc FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Optos Plc is registered with the FDA (registration 9617167) in Dunfermline, Fife, United Kingdom. It lists 5 device types. The FDA files 10 510(k) clearances under its listings, the newest dated May 9, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 9617167
FEI number: 3003060634
Address: Queensferry House, Carnegie Campus Enterprise Way, Dunfermline, Fife, United Kingdom, KY11 8GR
Owner or operator: OPTOS PLC (9035556)
Roles: Complaint file establishment, Exporter to the US, Manufacturer, Specification developer
First device listed: December 19, 2006
Registered through: 2026
Brand names listed: 200Dx, 200Tx, California, Daytona, Monaco, Monaco Pro, Optos Advance, Optos Advance 4 and more

Devices it lists

Device	Product code	Class	Role	Source
Armrest, Wheelchair	IML	1	Exporter to the US, Specification developer	accessdata.fda.gov
Ophthalmoscope, Ac-Powered	HLI	2	Manufacturer	accessdata.fda.gov
Ophthalmoscope, Laser, Scanning	MYC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
System, Image Management, Ophthalmic	NFJ	2	Manufacturer, Specification developer	accessdata.fda.gov
Tomography, Optical Coherence	OBO	2	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 9, 2024	K233602	P200TE (A10700)	OBO	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
August 18, 2023	K231673	P200TE (A10700)	OBO	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
July 31, 2019	K190732	P200TxE	OBO	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
February 28, 2018	K173707	P200TE	OBO	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
February 8, 2017	K162039	OptosAdvance 4.0 Software	NFJ	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
January 16, 2015	K142897	P200DTx	MYC	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
May 25, 2012	K113696	OPTOS ADVANCE	NFJ	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
August 19, 2011	K111628	P200T	MYC	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
September 30, 2010	K102492	P200MAAF	MYC	Substantially Equivalent	Optos Plc.	accessdata.fda.gov
February 3, 1999	K983999	PANORAMIC200 OPTHALMOSCOPE	HLI	Substantially Equivalent	Optos Plc.	accessdata.fda.gov

Compare with other makers

Updated May 9, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.