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 Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
510(k) Number K221987
Device Name Erchonia GVL
Applicant
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Applicant Contact Travis Sammons
Correspondent
Erchonia Corporation
650 Atlantis Rd.
Melbourne,  FL  32904
Correspondent Contact Travis Sammons
Regulation Number890.5500
Classification Product Code
NHN  
Date Received07/06/2022
Decision Date 09/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT00929305
NCT03941912
NCT04895618
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-