Device product
Ultra Renew Plus
Z-0821-2018
Product summary
- Event
- Event 79262
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1040 units
- Official record key
device-enforcement:Z-0821-2018
Official wording
Reason: Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Code information: none
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation