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U.S. Department of Health and Human Services

Class 3 Device Recall Elysiom Polychromatic LED Light Therapy System

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  Class 3 Device Recall Elysiom Polychromatic LED Light Therapy System see related information
Date Initiated by Firm June 04, 2019
Create Date June 24, 2021
Recall Status1 Terminated 3 on June 25, 2021
Recall Number Z-1943-2021
Recall Event ID 85106
510(K)Number K153389  
Product Classification Lamp, infrared, therapeutic heating - Product Code ILY
Product inLight Medical LED Pads used with Polychromatic light technology system
Code Information All serial numbers with cord connectors that have v-shaped notches
Recalling Firm/
Manufacturer		 Inlightened Partners LLC
16200 Addison Rd Ste 105
Addison TX 75001-5302
For Additional Information Contact
254-410-6721
Manufacturer 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.
FDA Determined
Cause 2		 Component change control
Action On 6/5/2019, Medical Device Recall Letters were emailed to customers. Customers were instructed to examine the connector on the cord attached to their pad and compare it to photos provided in the Medical Device Recall Letter. The connectors for recalled product contain a v-shaped notch. Customers in possession of a pad with the connector matching the photos were requested to complete an Acknowledgement and Receipt Form. Customers with questions were asked to call Customer Service at 1-800-455-4116.
Quantity in Commerce 926
Distribution Worldwide distribution - US Nationwide distribution in the states of CA, TX, NC, ID, CO, VA, FL, VT, AK, DC, MA, IL, AZ, MN, IA, TN, WI, WA, OK, MI, OH, GA, NY, IN, PA, NV, NJ, AR, CO , LA, MT, OR, SD, ND, MD, UT, MO, KY, NM, KS, AS, NE, WY, PR, MS and the country of Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = ILY and Original Applicant = IN LIGHT WELLNESS SYSTEMS, INC.
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