Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Powered Laser Surgical Instrument
510(k) Number K251824
Device Name Patriot Duo
Applicant
Patriot Laser, LLC
23030 N 15th St.
Phoenix,  AZ  85207
Applicant Contact Frank Ford
Correspondent
Patriot Laser, LLC
13423 Blanco Rd. #162
San Antonio,  TX  78216
Correspondent Contact Frank Ford
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/13/2025
Decision Date 10/27/2025
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
-
-