FDA Enforcement
Class II
Terminated
Truth Renew
Recall: Z-0820-2018
·
Reported March 7, 2018
Enforcement
- Recall Number
- Z-0820-2018
- Event ID
- 79262
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Accord Media, LLC
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- March 7, 2018
- Initiation Date
- December 4, 2017
- Classification Date
- March 1, 2018
- Termination Date
- May 28, 2020
- Address
- Apartment 16, 241 West 36th Street, New York, NY, 10018, United States
Description
Truth Renew
Reason
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Code Info
none
Distribution
US Nationwide
Quantity
30 units