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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K221417
Device Name CLAROX plus (Model: VX-100)
Applicant
Vsi Co., Ltd.
151-33, Namseok-Ro Nami-Myeon, Seowon-Gu
Cheongju-Si,  KR 28182
Applicant Contact Jake Yu
Correspondent
Lighten Bridge, LLC
4408 Tortuga Ln.
Mckinney,  TX  75070
Correspondent Contact Edward Park
Regulation Number892.1720
Classification Product Code
IZL  
Date Received05/16/2022
Decision Date 09/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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