ERCHONIA ZERONA

Fat Reducing Low Level Laser

ERCHONIA CORPORATION

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

Pre-market Notification Details

Device IDK121695
510k NumberK121695
Device Name:ERCHONIA ZERONA
ClassificationFat Reducing Low Level Laser
Applicant ERCHONIA CORPORATION 33 Golden Eagle Lane Littleton,  CO  80127
ContactKevin Walls
CorrespondentKevin Walls
ERCHONIA CORPORATION 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeOLI  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-06-07
Decision Date2012-08-23

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.