FDA.reportPublic FDA data

OPTOSOL CHEMISCHE PRODUKTE GMBH

Matched from indexed company URL: Optos Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041559433004155943OPTOSOL CHEMISCHE PRODUKTE GMBH1N2026-01-01Oskar-von-Miller-Strasse 6-8 Miesbach Bavaria DE 83714
30057449333005744933Optos Inc.1N2026-01-01155 Northboro Rd Ste 12 Southborough MA US 01772

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05057056003856Optos OCT/SLO - OCT+0441383843351gmcleod@optos.com
05057056010212Panoramic Ophthalmoscope - P200+4401383843347lmichie@optos.com

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
3334421034481202

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

PMN#

GUDID#

OCT Ophthalmoscope - The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer intended for in-vivo viewing and digital imaging of posterior ocular structures, including the retina, retinal nerve fiber layer and optic disc.The P200TE is a non-contact scanning laser ophthalmoscope and optical coherence tomographer. It is intended for in-vivo viewing, digital imaging, and analysis of posterior ocular structures, including the retina, retinal nerve fiber layer, ganglion cell complex (GCC) and optic disc, under mydriatic and non-mydriatic conditions.It is indicated for producing high resolution, ultra-widefield, en face reflectance images, autofluorescence images, axial cross-sectional images, three-dimensional images, retinal layer boundary analysis, optic nerve head analysis and thickness maps.The P200TE is indicated for use as a device to aid in the detection, diagnosis, documentation and management of retinal health and diseases that manifest in the retina.

OPTOS PUBLIC LIMITED COMPANY

2018-04-02