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Read specifications by model. E108A: 288 LEDs; 630 nm, 850 nm, and 460 nm; listed irradiance 25 mW/cm². RB-061 and RB-062: 280 LEDs, 9 modes, and 630 nm, 850 nm, 465 nm, and 530 nm light sources.
FDA 510(k) K253712 lists RB-061 and RB-062. Its decision is Substantially Equivalent, not FDA approved. Apply this information only to listed models and follow the relevant market requirements.