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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 K162334
Device Name U.S. Laser Worx Patriot 1 family of lasers
Applicant
U.S. Laser Worx
13423 Blanco Rd. #162
San Antonio,  TX  78216
Applicant Contact Frank Ford
Correspondent
U.S. Laser Worx
13423 Blanco Rd. #162
San Antonio,  TX  78216
Correspondent Contact Frank Ford
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/22/2016
Decision Date 04/27/2017
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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