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FDA 510(k)

G-EYE System

K-Number: K220158 · 2022-04-11

ApplicantSmart Medical Systems , Ltd.
Decision Date2022-04-11
Product CodeFDF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

G-EYE System is a medical device manufactured by Smart Medical Systems , Ltd.. It received FDA 510(k) clearance on 2022-04-11 under approval number K220158. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G-EYE System?

G-EYE System is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Smart Medical Systems , Ltd.. The 510(k) number is K220158.

When was G-EYE System approved by the FDA?

G-EYE System received FDA 510(k) clearance on 2022-04-11, under approval number K220158.

What company makes G-EYE System?

G-EYE System is manufactured by Smart Medical Systems , Ltd..

What is the FDA product code for G-EYE System?

The FDA product code for G-EYE System is FDF.

Other Devices by Smart Medical Systems , Ltd.

K202469G-EYE System K192588G-EYE System

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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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