OtoSight Middle Ear Scope

FDA UDI

Class II (US FDA UDI)

by Photonicare, Inc.

Identity

Trade Name: OtoSight Middle Ear Scope FDA UDI
Generic Name: Otoscope, endoscopic FDA UDI
Device Name: The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. It is available with and without a battery. FDA UDI
Model / Reference: 34R FDA UDI
Description: The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. It is available with and without a battery. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850013784004 FDA UDI
510(k) Number: K191804 FDA UDI
FDA Product Code: QJG FDA UDI
GMDN Term: Otoscope, endoscopic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1560 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Otoscope, endoscopic

OtoSight Middle Ear Scope by Photonicare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K191804 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Photonicare, Inc.

Sources (1)

FDA UDI 6393b361-3a2a-445b-8002-56cf8f8d84b3 35 fields · synced May 29, 2026