FDA 510(k)

Align Studio

K-Number: K232564 · 2024-03-12

Decision Date2024-03-12

Product CodePNN

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Align Studio is the device name listed in this FDA 510(k) record. The listed applicant is Laon Medi, Inc.. It received FDA 510(k) clearance on 2024-03-12 under 510(k) 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. The listed applicant is Laon Medi, Inc.. The 510(k) number is K232564.

When did Align Studio receive FDA 510(k) clearance?

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

Who is the listed applicant for Align Studio?

The FDA 510(k) record lists Laon Medi, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Align Studio?

The FDA product code for Align Studio is PNN.

Other records listing Laon Medi, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250198Laon Ortho

Related Devices (Code: PNN)

K260419LingOral Dental Design SystemHangzhou ChohoTech Co., Ltd.K253565SureSmile SoftwareDentsply Sirona, Inc.K252507SmileInspectorAmv Consulting, LLC K253343Celebrace SoftwareCelebrace K250198Laon OrthoLaon Medi, Inc.K241153Progressive Orthodontics AppProgressive Aligners, Inc.

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.