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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 Road
Melbourne, FL 32904
Applicant Contact
Travis Sammons
Correspondent
Erchonia Corporation
650 Atlantis Road
Melbourne, FL 32904
Correspondent Contact
Travis Sammons
Regulation Number
890.5500
Classification Product Code
NHN
Date Received
07/06/2022
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
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