Cleared Traditional

Laon Ortho

K250198 · Laon Medi, Inc. · Dental
Apr 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K250198 is an FDA 510(k) clearance for the Laon Ortho, a Orthodontic Software (Class II — Special Controls, product code PNN), submitted by Laon Medi, Inc. (Gwacheon-Si, KR). The FDA issued a Cleared decision on April 23, 2025, 90 days after receiving the submission on January 23, 2025. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K250198 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2025
Decision Date April 23, 2025
Days to Decision 90 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.