Photon Therapy Apparatus (BL-10)

The Photon Therapy Apparatus (BL-10) is an LED-based light therapy device that emits red (633±8nm), blue (417±8nm), yellow (590±8nm), and infrared (830±8nm) light to treat dermatological conditions. Indications include treatment of vascular and pigmented lesions, acne vulgaris, wrinkles, and temporary relief of muscle and joint pain.

The device features six types of optional irradiators in 3-panel and 5-panel configurations, each emitting three different colored light sources in various combinations. Output power ranges from 1.1–2.5W per diode depending on color, with maximum power densities of 80–100 mW/cm² for red and blue light. Treatment area is 825–1375 cm², with adjustable doses ranging up to 180 J/cm² and a standard 20-minute treatment time.

IEC 60601-1:2020 (general safety and essential performance), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60601-2-57:2023 (non-laser light source therapeutic equipment), IEC 62471:2006 (photobiological safety), and ANSI AAMI ES60601-1.

The indications for use are identical to the predicate devices across all wavelengths and clinical applications. Technical specifications including wavelengths, power densities, panel configurations, treatment times, and dose ranges are either the same or fall within the ranges established by three predicates. The device uses the same LED technology, wheeled structure, display interface, and safety classification (Class I) as the predicates, with no new technological differences that would raise novel safety or effectiveness questions.