FDA.reportPublic FDA data

510(k) K200203

Device
Infrascanner
Applicant
InfraScan, Inc.
510(k) number
K200203
Product code
OPT  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-10
Date received
2020-01-28
Regulation
882.1935
Classification name
Infrared Hematoma Detector
Medical specialty
Ophthalmic
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Baruch Ben Dor
Address
3508 Market St. Philadelphia PA US 19104 19104

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OPT  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241389Infrascanner Model 2500 (Model 2500)Infrascan, Inc.2024-12-12
K211617InfrascannerInfrascan, Inc.2022-02-09
K120949INFRASCANNERInfrascan, Inc.2013-01-11
DEN100002INFRASCANNER, MODEL 1000Infrascan, Inc.2011-12-13

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases