Invisa-RED ELITE

Fat Reducing Low Level Laser

IR Technology LLC

The following data is part of a premarket notification filed by Ir Technology Llc with the FDA for Invisa-red Elite.

Pre-market Notification Details

Device IDK192275
510k NumberK192275
Device Name:Invisa-RED ELITE
ClassificationFat Reducing Low Level Laser
Applicant IR Technology LLC 2707 Hampton TRL Woodstock,  GA  30189
ContactThomas A. Namynanik
CorrespondentThomas A. Namynanik
Vidantis Technologies, Inc 300 Lismore Terrace Woodstock,  GA  30189
Product CodeOLI  
CFR Regulation Number878.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-22
Decision Date2020-08-19

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