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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 K254197
Device Name Picasso Pro Diode Laser (002-00460)
Applicant
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Applicant Contact Robert Larsen
Correspondent
CAO Group, Inc.
4628 W. Skyhawk Dr.
West Jordan,  UT  84084
Correspondent Contact Robert Larsen
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
EEG   NVK  
Date Received12/23/2025
Decision Date 03/11/2026
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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