LED Light Therapy Device, ELIXIR MD™

Yassen Wellness, LLC

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K241293
Device name
LED Light Therapy Device, ELIXIR MD™
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-05-08
Decision date
2024-07-08
Submission type
Traditional
Technology type
LED(AI inferred)
Clinical applications
Pigment treatmentAcne treatmentSkin tighteningOther
Primary application
Acne treatment
Classification source
AI classified

Indications for Use

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 used 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.

Intended Use

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.

Device Description

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

Summary parsed at:2026-06-01 05:28:15 UTC

Predicate devices

1

K241293 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K241293 as a predicate