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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K230268
Device Name ZenPro 40
Applicant
BLUECORE COMPANY Co., Ltd.
Ace Hightech 21 #1203
48, Centurm Jungang-Ro, Haeundae-Gu
Busan,  KR 48059
Applicant Contact Bill Choi
Correspondent
Bio-Med USA, Inc.
27 New England Dr.
Ramsey,  NJ  07446
Correspondent Contact Young Chi
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
ONG  
Date Received01/31/2023
Decision Date 08/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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