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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 K243445
Device Name Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
Applicant
Bios S.R.L.
Via Guido Rossa 10/12
Vimodrone,  IT 20055
Applicant Contact Martina De Iturbe
Correspondent
Bios S.R.L.
Via Guido Rossa 10/12
Vimodrone,  IT 20055
Correspondent Contact Martina De Iturbe
Regulation Number878.4810
Classification Product Code
GEX  
Date Received11/06/2024
Decision Date 12/30/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Clinical Trials NCT04152707
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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