FDA 510(k)

Eye Prime

K-Number: K190786 · 2019-04-11

Decision Date2019-04-11

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Eye Prime is the device name listed in this FDA 510(k) record. The listed applicant is Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2019-04-11 under 510(k) number K190786. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Eye Prime?

Eye Prime is a medical device that received FDA 510(k) clearance on 2019-04-11. The listed applicant is Ellex Medical Pty, Ltd.. The 510(k) number is K190786.

When did Eye Prime receive FDA 510(k) clearance?

Eye Prime received FDA 510(k) clearance on 2019-04-11, under 510(k) number K190786.

Who is the listed applicant for Eye Prime?

The FDA 510(k) record lists Ellex Medical Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Eye Prime?

The FDA product code for Eye Prime is IYO.

Other records listing Ellex Medical Pty, Ltd. 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.

K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo

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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.