FDA 510(k)

EyeBOX EBX-4.1

K-Number: K242116 · 2025-04-04

Decision Date2025-04-04

Product CodeQEA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EyeBOX EBX-4.1 is the device name listed in this FDA 510(k) record. The listed applicant is Oculogica, Inc.. It received FDA 510(k) clearance on 2025-04-04 under 510(k) 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. The listed applicant is Oculogica, Inc.. The 510(k) number is K242116.

When did EyeBOX EBX-4.1 receive FDA 510(k) clearance?

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

Who is the listed applicant for EyeBOX EBX-4.1?

The FDA 510(k) record lists Oculogica, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Oculogica, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254086EyeBOX SNAP K212310EyeBOX (Model EBX-4)K201841EyeBOX K191183EyeBOX

Related Devices (Code: QEA)

K254086EyeBOX SNAPOculogica, Inc.K212310EyeBOX (Model EBX-4)Oculogica, Inc.K202927EYE-SYNCSyncthink, Inc.K201841EyeBOXOculogica, Inc.K191183EyeBOXOculogica, Inc.

Official Source

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