| Date Initiated by Firm | December 04, 2017 |
|---|
| Create Date | March 01, 2018 |
|---|
| Recall Status1 |
Terminated 3 on May 28, 2020 |
| Recall Number | Z-0822-2018 |
|---|
| Recall Event ID |
79262 |
| 510(K)Number | K132833 |
|---|
| Product Classification |
Over-the-counter powered light based laser for acne - Product Code OLP
|
| Product | Truth Renew Plus |
|---|
| Code Information |
none |
Recalling Firm/
Manufacturer |
Accord Media, LLC
Apartment 16
241 West 36th Street
New York NY 10018
|
| For Additional Information Contact |
917-640-8111 |
|---|
Manufacturer Reason
for Recall | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
|---|
FDA Determined
Cause 2 | 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 in Commerce | 67 units |
|---|
| Distribution | US Nationwide |
|---|
| 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 = OLP
|
|---|
