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FDA 510(k)

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

K-Number: K180378 · 2018-04-05

ApplicantOptomed OY
Decision Date2018-04-05
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is a medical device manufactured by Optomed OY. It received FDA 510(k) clearance on 2018-04-05 under approval number K180378. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is a medical device that received FDA 510(k) clearance on 2018-04-05. It is manufactured by Optomed OY. The 510(k) number is K180378.

When was Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module approved by the FDA?

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module received FDA 510(k) clearance on 2018-04-05, under approval number K180378.

What company makes Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is manufactured by Optomed OY.

What is the FDA product code for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module?

The FDA product code for Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module is HKI.

Related Clinical Trials

NCT07495345 Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001) COMPLETED

Other Devices by Optomed OY

K163021HAAG-STREIT FUNDUS MODULE 300

Related Devices (Code: HKI)

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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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