ERCHONIA PL2000

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

TUCO INNOVATIONS, INC.

The following data is part of a premarket notification filed by Tuco Innovations, Inc. with the FDA for Erchonia Pl2000.

Pre-market Notification Details

Device IDK012580
510k NumberK012580
Device Name:ERCHONIA PL2000
ClassificationPowered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Applicant TUCO INNOVATIONS, INC. 13 RED FOX LN. Littleton,  CO  80127
ContactKevin Wall
CorrespondentKevin Wall
TUCO INNOVATIONS, INC. 13 RED FOX LN. Littleton,  CO  80127
Product CodeNHN  
CFR Regulation Number890.5500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-09
Decision Date2002-01-17

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