FDA 510(k) Application Details - K192275

Device Classification Name	More FDA Info for this Device
510(K) Number	K192275
Device Name	invisa-RED ELITE
Applicant	IR Technology LLC 2707 Hampton TRL Woodstock, GA 30189 US Other 510(k) Applications for this Company
Contact	Thomas A. Namynanik Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/22/2019
Decision Date	08/19/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review