Erchonia PL Touch

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 Pl Touch.

Pre-market Notification Details

Device IDK153052
510k NumberK153052
Device Name:Erchonia PL Touch
ClassificationPowered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Applicant ERCHONIA CORPORATION 2021 COMMERCE DR Mckinney,  TX  75069
ContactSteven Shanks
CorrespondentKevin Walls
REGULATORY INSIGHT, INC. 33 Golden Eagle Lane Litteton,  CO  80127
Product CodeNHN  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-10-20
Decision Date2016-01-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00858985006063 K153052 000

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