FDA recall Z-0819-2018
Accord Media, LLC · Class II · device
Product
Ultra Renew
Reason for recall
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Distribution
US Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2017-12-04
- Report date
- 2018-03-07
- Termination date
- 2020-05-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- New York, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0819-2018