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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
510(k) Number K250516
Device Name SMART M-CELL PRP Concentration System
Applicant
Miracell Co., Ltd.
Rm. 405, 474 Dunchon-Daero, Jungwon-Gu
Seoul,  KR
Applicant Contact Sy Koo
Correspondent
Mtech Group, LLC
7505 Fannin St.
Suite 610
Houston,  TX  77054
Correspondent Contact Dave Kim
Regulation Number862.2050
Classification Product Code
QBV  
Date Received02/21/2025
Decision Date 04/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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