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Fed Regist. 2014 Jun 2;79(105):31205-14.

General and plastic surgery devices: reclassification of ultraviolet lamps for tanning, henceforth to be known as sunlamp products and ultraviolet lamps intended for use in sunlamp products. Final order.


The Food and Drug Administration (FDA or the Agency) is reclassifying ultraviolet (UV) lamps intended to tan the skin from class I (general controls) exempt from premarket notification to class II (special controls) and subject to premarket notification, and renaming them sunlamp products and UV lamps intended for use in sunlamp products. FDA is designating special controls that are necessary to provide a reasonable assurance of safety and effectiveness of the device. FDA is reclassifying this device on its own initiative based on new information.

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