Luminelle, Inc. - Feb. 21, 2023
Issue Date
Feb 21, 2023
Region
Southeast
Category
Device
$117.00
Contact Name
Allison London Brown
Contact Title
CEO
Address 1
158 Wind Chime Ct.
Address 2
Ste. 201
City
Raleigh
State
NC
Zip/Postal Code
27615-6433
Inspection Range
Feb 13, 2023 - Feb 21, 2023
Pages
9
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of infonnation that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Inga M. Warr