Ultraviolet or Infrared Ray Apparatus

Apparatus marketed for medical or therapeutic purposes — such as UV phototherapy units for psoriasis or infrared physiotherapy devices — are regulated by FDA as medical devices and require appropriate clearance or approval. Industrial UV curing systems, IR drying ovens, and similar manufacturing equipment are not subject to FDA medical device requirements. The importer's commercial invoice and product labeling must accurately reflect the intended use, as misrepresenting a medical device as industrial equipment to avoid FDA review constitutes a regulatory violation.

UV-A (315–400 nm) apparatus is used in phototherapy (PUVA treatment), tanning, and fluorescence inspection. UV-B (280–315 nm) narrowband units are the clinical standard for dermatological phototherapy of psoriasis and vitiligo. UV-C (100–280 nm) germicidal apparatus has seen rapid growth in air and surface disinfection applications. These distinctions matter for procurement because each wavelength range requires different lamp technology, safety enclosures, and — for medical devices — separate FDA product codes and predicate devices.