FDAnews
www.fdanews.com/articles/138014-uncleared-hair-removal-devices-net-korean-company-a-warning-letter

Uncleared Hair Removal Devices Net Korean Company a Warning Letter

June 30, 2011
The FDA has handed Korean devicemaker BNB Medical a warning letter for marketing its hair-removal devices in the U.S. without marketing clearance or approval.
The GMP Letter