Erchonia FX-405

Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

Erchonia Corporation

The following data is part of a premarket notification filed by Erchonia Corporation with the FDA for Erchonia Fx-405.

Pre-market Notification Details

Device IDK212595
510k NumberK212595
Device Name:Erchonia FX-405
ClassificationPowered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Applicant Erchonia Corporation 650 Atlantis Road Melbourne,  FL  32904
ContactSteven Shanks
CorrespondentTravis Sammons
Erchonia Corporation 650 Atlantis Road Melbourne,  FL  32904
Product CodeNHN  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-16
Decision Date2021-11-12

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