ERCHONIA EMERGE

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

ERCHONIA MEDICAL, INC.

The following data is part of a premarket notification filed by Erchonia Medical, Inc. with the FDA for Erchonia Emerge.

Pre-market Notification Details

Device IDK130996
510k NumberK130996
Device Name:ERCHONIA EMERGE
ClassificationPowered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Applicant ERCHONIA MEDICAL, INC. 33 Golden Eagle Lane Littleton,  CO  80127
ContactKevin Walls
CorrespondentKevin Walls
ERCHONIA MEDICAL, INC. 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeNHN  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-10
Decision Date2013-09-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858985006094 K130996 000
00858985006087 K130996 000

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