(a) Identification. A transilluminator, also known as a diaphanoscope or lightscanner, is an electrically powered device that uses low intensity emissions of visible light and near-infrared radiation (approximately 700-1050 nanometers (nm)), transmitted through the breast, to visualize translucent tissue for the diagnosis of cancer, other conditions, diseases, or abnormalities.

(b) Classification. Class III (premarket approval).

(c) Date premarket approval (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA by April 17, 2014, for any transilluminator for breast evaluation that was in commercial distribution before May 28, 1976, or that has, by April 17, 2014, been found to be substantially equivalent to any transilluminator for breast evaluation that was in commercial distribution before May 28, 1976. Any other transilluminator for breast evaluation shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.

[60 FR 36639, July 18, 1995, as amended at 79 FR 3094, Jan. 17, 2014]