Device product
Pink Luminous Breast, Breast transilluminator
Z-2269-2024
Product summary
- Firm
- Silkprousa LLC
- Event
- Event 94539
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2000 devices
- Official record key
device-enforcement:Z-2269-2024
Official wording
Reason: Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Code information: Product is not lot coded, all devices are subject
Distribution pattern: US Nationwide distribution in the states of WA, RI.
Derived failure modes
-
Unknown
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval