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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 K250198
Device Name Laon Ortho
Applicant
LAON MEDI Inc.
60 Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840
C-504
Gwacheon-si,  KR 13840
Applicant Contact Mina Yun
Correspondent
LAON MEDI Inc.
60 Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840
C-504
Gwacheon-si,  KR 13840
Correspondent Contact Mina Yun
Regulation Number872.5470
Classification Product Code
PNN  
Subsequent Product Code
LLZ  
Date Received01/23/2025
Decision Date 04/23/2025
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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