THL1 LASER

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 Thl1 Laser.

Pre-market Notification Details

Device IDK100509
510k NumberK100509
Device Name:THL1 LASER
ClassificationPowered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Applicant ERCHONIA CORPORATION 33 Golden Eagle Lane Littleton,  CO  80127
ContactKevin Walls
CorrespondentKevin Walls
ERCHONIA CORPORATION 33 Golden Eagle Lane Littleton,  CO  80127
Product CodeNHN  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-22
Decision Date2010-06-08

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