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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 K192331
Device Name LaseMD LEO Laser System
Applicant
Lutronic Global
19 Fortune Drive
Billerica,  MA  01821
Applicant Contact James Childs
Correspondent
Lutronic Global
19 Fortune Drive
Billerica,  MA  01821
Correspondent Contact James Childs
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/27/2019
Decision Date 11/12/2019
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
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