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ELIXIR MDTM use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions.

The red light (633±10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions.

The blue light (417±10 nm wavelength); is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.

The Yellow light (590±10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides.

The infrared light (835±15nm wavelength) is generally use for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

The ELIXIR MD™ uses specific wavelengths of light, produced by LEDs (light emitting diodes), to manage aesthetic conditions.

The device produces light in the red-light region of the spectrum (633 ± 10m), in the blue light regions of the light spectrum (417 ± 10m), the yellow light area (590 ± 10nm) and the infrared light region of the light spectrum (835 ± 15m).

The ELIXIR MD™ is equipped with two irradiators. The RBY irradiator has five panels, each of which emits three different colors of light sources (red light, yellow light); The RBI irradiator has five panels. Each panel emits three different colors of light sources (red light, blue light, infrared light).

This document is a 510(k) Premarket Notification from the FDA for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on clinical performance. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or treatment efficacy, will not be present in this document.

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Acceptance Criteria and Device Performance:

The primary "acceptance criterion" for this 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device (K222751 LED Light Therapy Device, KN-7000L). The device's performance is not independently evaluated against pre-defined clinical success metrics. Instead, its technical specifications and intended use are compared to the predicate device.

The table in Section 8 provides a direct comparison demonstrating "same" or "—" (indicating a difference in proprietary name or manufacturer, not affecting substantial equivalence) across various parameters. This table serves as the performance "proof" by showing the proposed device matches the predicate.

Table of Acceptance Criteria (from a regulatory perspective - Substantial Equivalence) and Reported Device Performance:

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