FDA-Device2024-07-17Class II
Pink Luminous Breast, Breast transilluminator
Silkprousa LLC
Hazard
Firm is marketing and distributing the Pink Luminous Breast device without premarket approval
Sold states
US Nationwide distribution in the states of WA, RI.
Affected count
2000 devices
Manufactured in
3257 Nw 7th Avenue Cir, N/A, Miami, FL, United States
Products
Pink Luminous Breast, Breast transilluminator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2269-2024Don't want to check this manually?
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