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FDA 510(k)

EyeBOX EBX-4.1

K-Number: K242116 · 2025-04-04

ApplicantOculogica, Inc.
Decision Date2025-04-04
Product CodeQEA
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EyeBOX EBX-4.1 is a medical device manufactured by Oculogica, Inc.. It received FDA 510(k) clearance on 2025-04-04 under approval number K242116. The device is classified under product code QEA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EyeBOX EBX-4.1?

EyeBOX EBX-4.1 is a medical device that received FDA 510(k) clearance on 2025-04-04. It is manufactured by Oculogica, Inc.. The 510(k) number is K242116.

When was EyeBOX EBX-4.1 approved by the FDA?

EyeBOX EBX-4.1 received FDA 510(k) clearance on 2025-04-04, under approval number K242116.

What company makes EyeBOX EBX-4.1?

EyeBOX EBX-4.1 is manufactured by Oculogica, Inc..

What is the FDA product code for EyeBOX EBX-4.1?

The FDA product code for EyeBOX EBX-4.1 is QEA.

Other Devices by Oculogica, Inc.

DEN170091EyeBOX K191183EyeBOX K201841EyeBOX K212310EyeBOX (Model EBX-4)

Related Devices (Code: QEA)

DEN170091EyeBOXOculogica, Inc. K191183EyeBOXOculogica, Inc. K201841EyeBOXOculogica, Inc. K212310EyeBOX (Model EBX-4)Oculogica, Inc. K202927EYE-SYNCSyncthink, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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