FDA 510(k)

LOYON

K-Number: K162217 · 2017-03-23

Decision Date2017-03-23

Product CodeFRO

DecisionSubstantially Equivalent

Device Summary

LOYON is a medical device manufactured by Oculus Innovative Sciences. It received FDA 510(k) clearance on 2017-03-23 under approval number K162217. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOYON?

LOYON is a medical device that received FDA 510(k) clearance on 2017-03-23. It is manufactured by Oculus Innovative Sciences. The 510(k) number is K162217.

When was LOYON approved by the FDA?

LOYON received FDA 510(k) clearance on 2017-03-23, under approval number K162217.

What company makes LOYON?

LOYON is manufactured by Oculus Innovative Sciences.

What is the FDA product code for LOYON?

The FDA product code for LOYON is FRO. This falls under the Anesthesiology category.

Other Devices by Oculus Innovative Sciences

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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.