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FDA 510(k)

Align Studio

K-Number: K232564 · 2024-03-12

ApplicantLaon Medi, Inc.
Decision Date2024-03-12
Product CodePNN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Align Studio is a medical device manufactured by Laon Medi, Inc.. It received FDA 510(k) clearance on 2024-03-12 under approval number K232564. The device is classified under product code PNN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Align Studio?

Align Studio is a medical device that received FDA 510(k) clearance on 2024-03-12. It is manufactured by Laon Medi, Inc.. The 510(k) number is K232564.

When was Align Studio approved by the FDA?

Align Studio received FDA 510(k) clearance on 2024-03-12, under approval number K232564.

What company makes Align Studio?

Align Studio is manufactured by Laon Medi, Inc..

What is the FDA product code for Align Studio?

The FDA product code for Align Studio is PNN.

Other Devices by Laon Medi, Inc.

K250198Laon Ortho

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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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