Cleared Traditional

Align Studio

K232564 · Laon Medi, Inc. · Dental

Mar 2024

Decision

201d

Days

Class 2

Risk

About This 510(k) Submission

K232564 is an FDA 510(k) clearance for the Align Studio, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by Laon Medi, Inc. (Seongnam-Si, KR). The FDA issued a Cleared decision on March 12, 2024, 201 days after receiving the submission on August 24, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number	K232564 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2023
Decision Date	March 12, 2024
Days to Decision	201 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF

Device Classification

Product Code	PNN — Orthodontic Software
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.5470
Definition	The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.