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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 K230340
Device Name Lucas Plus
AMT Engineering Co., Ltd
811-812 Byoksan Technopia 560, Duchon Daero
Jungwon gu, SeongNam-si
Gyeonggi do,  KR 13230
Applicant Contact SeoungSoo Choi
Bio-Med USA Inc
27 New England Dr
Ramsey,  NJ  07446
Correspondent Contact Young Chi
Regulation Number878.4810
Classification Product Code
Date Received02/07/2023
Decision Date 05/04/2023
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