(61 days)
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.
Here's an analysis of the provided text in relation to your request:
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:
| Acceptance Criterion (for Substantial Equivalence Goal) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Product Code: GEX | Same |
| Regulation Number: 21 CFR 878.4810 | Same |
| Indications for Use: | Same |
| - General dermatological conditions | Same |
| - Red light (633±10nm) for superficial, benign vascular, pigmented lesions | Same |
| - Blue light (417±10nm) for moderate inflammatory acne vulgaris | Same |
| - Yellow light (590±10nm) for periorbital wrinkles and rhytides | Same |
| - Infrared light (835±15nm) for temporary relief of minor muscle/joint pain, arthritis, muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; increasing local blood circulation | Same |
| Wavelength(s) (nm): | Same |
| - RBY irradiator (Red, Blue, Yellow) | Same (Red 633±10nm, Blue 417±10nm, Yellow 590±10nm) |
| - RBI irradiator (Red, Blue, Infrared) | Same (Red 633±10nm, Blue 417±10nm, Infrared 835±15nm) |
| Panel Type: | Same (RBY & RBI irradiators with 5 panels each) |
| Number of LEDs per panel (Red, Blue, Yellow, Infrared) | Same (e.g., Red: 465EA, Blue: 470EA, Yellow: 465EA, Infrared: 465EA) |
| Output Power (energy power of diode): 0.5W | Same |
| Maximum power density (mW/cm²): | Same |
| - Red light: 20-96 | Same |
| - Blue light: 10-120 | Same |
| - Yellow light: 5-35 | Same |
| - Infrared: |
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.