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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngeal Injection Set With Led Light
510(k) Number K232177
Device Name Lightin System, Lightin, Lightin Generator
Applicant
Solmedix Co., Ltd.
#706, 330, Seongarm-Ro, Mapo-Gu
Seoul,  KR 03920
Applicant Contact Hyeroung Lee
Correspondent
Mtechgroup
7505 Fannin St. Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number874.4420
Classification Product Code
SBS  
Subsequent Product Code
EQH  
Date Received07/24/2023
Decision Date 07/10/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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