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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Software
510(k) Number K232564
Device Name Align Studio
Applicant
Laon Medi, Inc.
404, Bundang Techno Park B, 723, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13511
Applicant Contact Mina Yun
Correspondent
Laon Medi, Inc.
404, Bundang Techno Park B, 723, Pangyo-Ro, Bundang-Gu
Seongnam-Si,  KR 13511
Correspondent Contact Mina Yun
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received08/24/2023
Decision Date 03/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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