FDA-Device2018-03-07Class II
Ultra Renew Plus
Accord Media, LLC
Hazard
Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation
Sold states
US Nationwide
Affected count
1040 units
Manufactured in
Apartment 16, 241 West 36th Street, New York, NY, United States
Products
Ultra Renew Plus
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0821-2018Don't want to check this manually?
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