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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 K260489
Device Name LASEmaR 1500
Applicant
Eufoton S.R.L.
Via Flavia 23/1
Trieste,  IT 34148
Applicant Contact Andrea Buoso
Correspondent
Eufoton S.R.L.
Via Flavia 23/1
Trieste,  IT 34148
Correspondent Contact Andrea Buoso
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/13/2026
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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