SOLIUS PRO UVB Light Panel

The SOLIUS PRO UVB Light Panel is a portable, over-the-counter photobiomodulation device designed for home or facility use that stimulates vitamin D production through controlled UVB light exposure (280-315 nm wavelength). It incorporates personalized dosing based on individual skin type measurement, mobile app control with safety interlocks, and protective eyewear enforcement to minimize UV exposure risks while achieving therapeutic vitamin D synthesis in users 22 years and older.

SOLIUS PRO uses 132 precision UVB LEDs with a single narrow spectral peak at 294 nm and >95% UVB content (280-315 nm), delivering 242.53 µW/cm² with ±20% output uniformity. The predicate Sperti uses a single mercury arc lamp with multiple spectral peaks and 36.51% UVB output at 365.40 µW/cm² with 125% maximum variation. SOLIUS PRO meets current IEC 60601 medical device safety standards and ACGIH UV exposure guidelines, whereas Sperti predates these standards. Both operate at similar voltages but SOLIUS is more energy efficient (70 VA vs 400 W).

IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 60601-2-57, IEC 60601-2-83, IEC 62304, IEC 62366-1, IEC 62471:2006, AAMI TIR57:2016, AAMI TIR12:2020, ANSI/AAMI ST98:2022, AAMI/ANSI/HE75:2009, ISTA 3A 2018, and FDA guidance on reprocessing medical devices.

SOLIUS PRO is substantially equivalent to the Sperti Sun Lamp Model P-164 because both devices share the same fundamental mode of action—UVB light exposure to stimulate vitamin D production in skin—and same intended use as OTC devices. Technical differences (LED vs. mercury lamp, tighter spectrum targeting, modern safety standards, personalized dosing) represent improvements rather than new safety or effectiveness questions. Clinical testing demonstrated 96% of diverse skin types received appropriate sub-MED doses with 100% adverse event-free outcomes, confirming substantial equivalence despite technological enhancements.