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FDA 510(k)

Phoenix ICON, Phoenix ICON GO

K-Number: K223575 · 2023-09-06

ApplicantNeolight, LLC
Decision Date2023-09-06
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Phoenix ICON, Phoenix ICON GO is a medical device manufactured by Neolight, LLC. It received FDA 510(k) clearance on 2023-09-06 under approval number K223575. 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 Phoenix ICON, Phoenix ICON GO?

Phoenix ICON, Phoenix ICON GO is a medical device that received FDA 510(k) clearance on 2023-09-06. It is manufactured by Neolight, LLC. The 510(k) number is K223575.

When was Phoenix ICON, Phoenix ICON GO approved by the FDA?

Phoenix ICON, Phoenix ICON GO received FDA 510(k) clearance on 2023-09-06, under approval number K223575.

What company makes Phoenix ICON, Phoenix ICON GO?

Phoenix ICON, Phoenix ICON GO is manufactured by Neolight, LLC.

What is the FDA product code for Phoenix ICON, Phoenix ICON GO?

The FDA product code for Phoenix ICON, Phoenix ICON GO is HKI.

Other Devices by Neolight, LLC

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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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