LED Technologies, LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1581-2016Class IIreVive Light Therapy Pain Relief Device (Model Number: RVPNSYS) Product Usage: The reVive LighMarch 30, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K223482reVive Light Therapy® Wrinkle and Acne LED DeviceDecember 21, 2022
K221430reVive Light Therapy LED Cleansing SystemJuly 27, 2022
K210968reVive Light Therapy EssentialsDecember 21, 2021
K210965reVive Light Therapy EssentialsDecember 15, 2021
K183247dpl FacewareMarch 14, 2019
K183118dpl SpotLiteFebruary 7, 2019
K180447reVive Light Therapy LED Cleansing SystemJune 4, 2018
K180445reVive Light Therapy LED Ultrasonic Wrinkle SystemMay 15, 2018
K180320dpl IIa PanelApril 3, 2018
K172662reVive PerioralJanuary 9, 2018
K171386dpl SpectraLiteAugust 7, 2017
K171390dpl II PanelAugust 3, 2017
K141181NUVE FOR WRINKLES, DPL NUVE FOR WRINKLESMarch 31, 2015
K101382DPL NUVENovember 9, 2010
K081570DPL THERAPY SYSTEMNovember 7, 2008