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FDA 510(k)

U-Lite PRO

K-Number: K232285 · 2024-01-11

ApplicantSonoscanner Sarl
Decision Date2024-01-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

U-Lite PRO is a medical device manufactured by Sonoscanner Sarl. It received FDA 510(k) clearance on 2024-01-11 under approval number K232285. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the U-Lite PRO?

U-Lite PRO is a medical device that received FDA 510(k) clearance on 2024-01-11. It is manufactured by Sonoscanner Sarl. The 510(k) number is K232285.

When was U-Lite PRO approved by the FDA?

U-Lite PRO received FDA 510(k) clearance on 2024-01-11, under approval number K232285.

What company makes U-Lite PRO?

U-Lite PRO is manufactured by Sonoscanner Sarl.

What is the FDA product code for U-Lite PRO?

The FDA product code for U-Lite PRO is IYN.

Related Devices (Code: IYN)

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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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