FDA Tightens Control on Sunlamps, New Devices Have 90 Days for 510(k)

Manufacturers of ultraviolent sunlamps used in tanning beds have 450 days to submit 510(k)s on lamps now in use, an FDA final reclassification order on the preamendment devices says. Makers of new sunlamp products must begin submitting premarket notifications within 90 days.
Devices & Diagnostics Letter