FDA Device

Ultra Renew

Hazard

Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation

What You Should Do

Remedy

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.

Products

Ultra Renew
Brand
Accord Media, LLC Apartment
UPC
none

Units Affected

524 units