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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K251414
Device Name Miracu™ Polydioxanone (PDO) Suture and Needle (MONO)
Applicant
Feeltech Co., Ltd.
4th Floor, Standard Factory5-Dong, 1st Floor
Standard Factory2-Dong 15, Jayumuyeok 2-Gil
Gunsan-Si,  KR 54001
Applicant Contact Choi Cheol-Ho
Correspondent
Albert Rego PHD, Inc (D.B.A Rego Associates)
25401 Cabot Rd.
# 122
Laguna Hills,  CA  92653
Correspondent Contact Albert Rego
Regulation Number878.4840
Classification Product Code
NEW  
Date Received05/07/2025
Decision Date 10/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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