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510(k) Data Aggregation

    K Number
    K252960

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-01-16

    (122 days)

    Product Code
    Regulation Number
    878.4635
    Age Range
    22 - 120
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    SOLIUS PRO is an over-the-counter (OTC) light panel intended to stimulate production of Vitamin D in people 22 years and older.

    Device Description

    The SOLIUS PRO is a portable, over-the-counter (OTC) photobiomodulation light panel designed for home or facility use. The device stimulates vitamin D production through controlled exposure of a targeted ultraviolet B (UVB) spectrum ranging from 280-315 nm. Specialized UVB LEDs deliver a controlled UVB emission aligned with the action spectrum for vitamin D synthesis while incorporating multiple technological and software safety features.

    The SOLIUS PRO provides a uniform light output across an area of exposed skin on the torso to optimize vitamin D production while minimizing unnecessary exposure to the face and eyes. A height-adjustable hanging system positions the panel at shoulder level, and an integrated distance sensor ensures the user maintains the optimal distance for both safety and effectiveness.

    Before the first therapy session, the Personalized Dosing System uses a built-in optical sensor to quantifiably measure the Individual Typology Angle degree of the user's skin and a user response to a skin history question. The system calculates a personalized dose below 1 Minimal Erythema Dose (MED) that is delivered for a precisely controlled exposure time to stimulate vitamin D production and mitigate the risk of erythema.

    Therapy sessions are initiated and monitored through a mobile application. The mobile application enforces the use of the provided protective eyewear by performing a facial scan before a session can begin. Once therapy begins, the system provides real-time visual and audio feedback from the distance sensor to assist user positioning. The mobile application records dosing information and user feedback and manages session scheduling and dose adjustments to ensure safe operation.

    AI/ML Overview

    N/A

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