PHOTONICARE INC

FDA Device Registration & Listing · Durham, NC, US · Registration 3016597890

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
3016597890
FEI Number
3016597890
Entity Name
PHOTONICARE INC
City/State/Country
Durham, NC, US
Establishment Address
2800 Meridian Pkwy Ste 175, Durham, NC 27713, US
Establishment Type(s)
Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198,Remanufacture Medical Device
Owner / Operator
PhotoniCare Inc (Owner Number: 10062812)
Owner / Operator Contact Address
2800 Meridian Parkway STE 175, Durham, NC 27713, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K191804
PMA Number
N/A

All Registered Proprietary Names

OtoSight Middle Ear Scope TOMi Scope OtoSight Middle Ear Scope

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QJG Device System, Imaging, Tympanic Membrane And Middle Ear Radiology Class 2 892.1560 2023-12-08
QJG Device System, Imaging, Tympanic Membrane And Middle Ear Radiology Class 2 892.1560 2020-03-09

Official Correspondent

Ryan Shelton

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PhotoniCare 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 3016597890. Last updated year: 2026. Please use registration number 3016597890 when referencing this establishment in official correspondence.
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