SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)

The SnugLit Wearable Phototherapy System is a neonatal phototherapy device that delivers therapeutic blue light to infants via a Light Mat enclosed in a Disposable Swaddle. It treats infant hyperbilirubinemia (neonatal jaundice) and can be used in hospitals or homes by licensed medical practitioners or caregivers under supervision. The device is designed for infants weighing 1.5–5.5 kg and measuring 40.5–57.5 cm in length.

Both the SnugLit and predicate BiliTouch use blue LED light at similar wavelengths (SnugLit 459–480 nm vs. BiliTouch 455–465 nm) to treat hyperbilirubinemia. The SnugLit provides a larger illuminated area (1080 cm² vs. 420 cm²) to maximize body surface coverage. Both include a control box with LCD display, rechargeable battery, light-emitting pad, disposable cover, and power adapter. The SnugLit offers more precise treatment-time monitoring via a run-time counter displayed in hours:minutes:seconds.

ISO 10993 series (biocompatibility: cytotoxicity, skin sensitization, irritation); IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-1-11, IEC 60601-2-50 (electrical safety and phototherapy basics); IEC 62471 (photobiological safety); IEC 62304 (software validation); ASTM D4169 (transit testing); and FDA's Human Factors guidance (February 2016).

The SnugLit is substantially equivalent to the BiliTouch because both devices treat hyperbilirubinemia using blue LED light on the same operating principle, target identical patient populations (infants with neonatal jaundice in hospital or home settings), operate within the same electrical safety standards, and deliver light output within the American Academy of Pediatrics recommended wavelength range (460–490 nm). Bench testing confirmed comparable light irradiance, thermal safety, and biocompatibility, with the SnugLit's larger treatment area and enhanced monitoring features providing refinements rather than fundamental differences in safety or effectiveness.