Lamp Manufacturers Must Submit 510(k)s in 90 Days
Manufacturers of tanning bed ultraviolet and sunlamps that were offered for sale prior to Sept. 2, 2014, must submit 510(k)s to the FDA by Aug. 26.
The agency issued a final reclassification order in June 2014 moving the products from Class 1 to Class II, subjecting them to 510(k) scrutiny. For products not on the market before Sept. 2, 2014, and for products offered for sale before that date that required a 510(k) for a significant modification, the effective date for the 510(k) requirement was Sept. 2.
The order didn’t apply to UV lamps used to treat dermatological conditions or cancer. Those lamps were already classified as Class II devices.
To obtain clearance, devicemakers must demonstrate their tanning bed lamp meets performance standards such as wavelength, energy density and lamp life, has properly functioning safety features and is mechanically safe. Read the final order at . — Jonathon Shacat