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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 With Microbeam\Fractional Output
510(k) Number K233550
Device Name MOSAIC 3D (Surgical Laser)
Applicant
Lutronic Aesthetic
19 Fortune Dr.
Billerica,  MA  01821
Applicant Contact Sarah Dunne
Correspondent
Lutronic Corporation
Lutronic Center
219, Sowon-Ro
Deogyang-Gu,  KR 410220
Correspondent Contact Kevin O'Connell
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received11/03/2023
Decision Date 01/02/2024
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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