FDA 510(k)

EyeBOX (Model EBX-4)

K-Number: K212310 · 2021-12-22

Decision Date2021-12-22

Product CodeQEA

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EyeBOX (Model EBX-4) is the device name listed in this FDA 510(k) record. The listed applicant is Oculogica, Inc.. It received FDA 510(k) clearance on 2021-12-22 under 510(k) number K212310. 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 (Model EBX-4)?

EyeBOX (Model EBX-4) is a medical device that received FDA 510(k) clearance on 2021-12-22. The listed applicant is Oculogica, Inc.. The 510(k) number is K212310.

When did EyeBOX (Model EBX-4) receive FDA 510(k) clearance?

EyeBOX (Model EBX-4) received FDA 510(k) clearance on 2021-12-22, under 510(k) number K212310.

Who is the listed applicant for EyeBOX (Model EBX-4)?

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 (Model EBX-4)?

The FDA product code for EyeBOX (Model EBX-4) 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 K242116EyeBOX EBX-4.1 K201841EyeBOX K191183EyeBOX

Related Devices (Code: QEA)

K254086EyeBOX SNAPOculogica, Inc.K242116EyeBOX EBX-4.1Oculogica, 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.