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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 K251699
Device Name The Botticelli (Model: Athena)
Applicant
Bellamia Technologies, Inc.
285 W Central Pkwy., Suite 1735
Altamonte Springs,  FL  32714
Applicant Contact Ahmed Mohammed
Correspondent
Bellamia Technologies, Inc.
285 W Central Pkwy., Suite 1735
Altamonte Springs,  FL  32714
Correspondent Contact Ahmed Mohammed
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/02/2025
Decision Date 10/08/2025
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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