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RETeval™

FDA UDI

Class II (US FDA UDI)

by LKC Technologies

Identity

Trade Name
RETeval™ FDA UDI
Generic Name
Electroretinograph electrode FDA UDI
Device Name
Bag of 25 pairs (1-right & 1-left per pair) of Small electrodes for use with the RETeval visual electrophysiology system. FDA UDI
Model / Reference
Sensor Strips FDA UDI
Description
Bag of 25 pairs (1-right & 1-left per pair) of Small electrodes for use with the RETeval visual electrophysiology system. FDA UDI

Identifiers

Catalog Number
Sensor Strips FDA UDI
Primary DI / UDI-DI
10857901006313 FDA UDI
510(k) Number
K142567 FDA UDI
FDA Product Code
GXY FDA UDI
GMDN Term
Electroretinograph electrode FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electroretinograph electrode

RETeval™ by LKC Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electroretinograph electrode.

Cleared under the same submission

K142567 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
LKC Technologies

Sources (1)

  • FDA UDI 950fa01b-4b64-4b16-b07c-4688edc262d9 36 fields · synced May 30, 2026