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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 Dr. 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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