FDA.reportPublic FDA data

Optos Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057449333005744933Optos Inc.1N2026-01-01155 Northboro Rd Ste 12 Southborough MA US 01772

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1626481996681527K983999PANORAMIC200 OPTHALMOSCOPEHLI1999-02-03
1626482065820845K233602P200TE (A10700)OBO2024-05-09
1626481061920837K231673P200TE (A10700)OBO2023-08-18
1626481785114549K173707P200TEOBO2018-02-28
1626481548501384K142897P200DTxMYC2015-01-16
1626481367859071K111628P200TMYC2011-08-19
1626481465854634K102492P200MAAFMYC2010-09-30
1626481538434500K092837OTI-SCAN 3000IYO2009-12-23
1626481843698819K080460SPECTRAL OCT/SLOOBO2008-11-14
1626481207899507K060424PANORAMIC, MODEL 200MAMYC2006-03-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OBO42024-05-09
MYC42015-01-16
IYO12009-12-23
HLI11999-02-03