INFRASCAN, INC.

FDA Device Registration & Listing · Media, PA, US · Registration 3006059345

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006059345
FEI Number
3006059345
Entity Name
INFRASCAN, INC.
City/State/Country
Media, PA, US
Establishment Address
600 N Jackson Street, Suite 3, Media, PA 19063, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
InfraScan, Inc. (Owner Number: 9095019)
Owner / Operator Contact Address
1384 Karen Ln, --, Radnor, PA 19087, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200203
PMA Number
N/A

All Registered Proprietary Names

Infrascanner Model 1000 Infrascanner Model 2000 Infrascanner Model 2500

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OPT Infrared Hematoma Detector Ophthalmic Class 2 882.1935 2011-12-15
OPT Infrared Hematoma Detector Ophthalmic Class 2 882.1935 2013-01-21
OPT Infrared Hematoma Detector Ophthalmic Class 2 882.1935 2020-11-06

Official Correspondent

Baruh Ben Dor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InfraScan, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006059345. Last updated year: 2026. Please use registration number 3006059345 when referencing this establishment in official correspondence.
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