Recall Z-0820-2018 ยท OLP Over-The-Counter Powered Light Based Laser For Acne
Accord Media, LLC
Truth Renew
| Date | Dec 4, 2017 |
| Status | Terminated |
| Reason | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| Root cause | Device Design |
| Action | On December 4, 2017, Accord Media distributed Urgent Medical Device Field Action notices and Response Forms to customers via courier service. Customers were instructed to inspect stock and identify affected product whereby the would apply a label to the product which reads "DO NOT USE GREEN LIGHT FUNCTIONALITY - NOT FDA CLEARED FOR USE". Customers are encouraged to complete and return the response form via email to: customerservice@truthinaging.com. |
| Quantity | 30 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132833 | ULTRA RENEW PLUS Accord Media, Jun 17, 2014 |