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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 K244060
Device Name eCO2 3D
Applicant
Lutronic Corporation
Lutronic Center
219, Sowon-Ro
Deogyang-Gu,  KR 410220
Applicant Contact Sarah Dunne
Correspondent
Cynosure, Inc.
3/5 Carlisle Rd.
Westford,  MA  01886
Correspondent Contact Sean Reynolds
Regulation Number878.4810
Classification Product Code
ONG  
Subsequent Product Code
GEX  
Date Received12/31/2024
Decision Date 07/31/2025
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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