ERCHONIA VERJU LASER SYSTEM WITH MASSAGER

Fat Reducing Low Level Laser

ERCHONIA MEDICAL, INC.

The following data is part of a premarket notification filed by Erchonia Medical, Inc. with the FDA for Erchonia Verju Laser System With Massager.

Pre-market Notification Details

Device IDK130922
510k NumberK130922
Device Name:ERCHONIA VERJU LASER SYSTEM WITH MASSAGER
ClassificationFat Reducing Low Level Laser
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 CodeOLI  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-03
Decision Date2013-05-17

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