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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 K241951
Device Name Lasya-Trinity
Applicant
BLUECORE COMPANY Co., Ltd.
#1203, 48, Centurm Jungang-Ro, Haeundae-Gu
Busan,  KR 48059
Applicant Contact Sang Mi Oh
Correspondent
BLUECORE COMPANY Co., Ltd.
#1203, 48, Centurm Jungang-Ro, Haeundae-Gu
Busan,  KR 48059
Correspondent Contact Sang Mi Oh
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/03/2024
Decision Date 10/10/2024
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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