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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 K241407
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
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/17/2024
Decision Date 06/14/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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