Recall Z-1943-2021— Inlightened Partners LLC

Name: FDA recall Z-1943-2021
Creator: U.S. Food and Drug Administration
Published: 2019-06-04

Class III · Terminated

Class III FDA medical device recall by Inlightened Partners LLC, initiated 2019-06-04, terminated 2021-06-25. It names one FDA 510(k) clearance: K153389. Product: inLight Medical LED Pads used with Polychromatic light technology system. Reason: LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down..

Recalling firm: Inlightened Partners LLC
Classification: Class III
Status: Terminated
Initiated: 2019-06-04
Terminated: 2021-06-25
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K153389 — Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc.·cleared 2016-03-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

inLight Medical LED Pads used with Polychromatic light technology system

Reason for recall

LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down.

Data sourced from openFDA. This site is unofficial and independent of the FDA.