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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 K254199
Device Name PicoreMax (PicoreMax)
Applicant
BLUECORE COMPANY Co., Ltd.
#402-404,34,Yarl 3-Gil, Mulgeum-Eup
Yangsan-Si, Gyeonsangnam-Do
Yangsan,  KR 50652
Applicant Contact Kwon Bu Gyeong
Correspondent
BLUECORE COMPANY Co., Ltd.
#402-404,34,Yarl 3-Gil, Mulgeum-Eup
Yangsan-Si, Gyeonsangnam-Do
Yangsan,  KR 50652
Correspondent Contact Kwon Bu Gyeong
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/29/2025
Decision Date 09/24/2026
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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