Soli-Lite LG4 Galileo

Silhouet-Tone Corporation

Country / region:Canada (CA)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Canada (CA)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K192755
Device name
Soli-Lite LG4 Galileo
Country / region
Canada(CA)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-09-30
Decision date
2019-12-20
Submission type
Traditional
Technology type
LED(AI inferred)
Clinical applications
Acne treatmentSkin resurfacingSkin tighteningOther
Primary application
Acne treatment
Classification source
AI classified

Indications for Use

Blue (410-415nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Red (620-633nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; 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. Blue (420nm+/-10nm) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Combination of Red (628nm +/-10nm) and Blue (420nm +/-10nm) is intended to emit energy in the red, blue regions of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. Anti-Aging Red (628nm +/-10nm) and Anti-Aging Infrared (880nm+/-10nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Infrared (880nm +/-10nm) is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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

Blue (410-415nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. Red (620-633nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum to provide topical heating for the purpose of elevating tissue temperature; 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 Photo-Therapy Device Soli-Lite LG4 Galileo is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs). The device produces light in the following regions of the light spectrum: Red (620-633nm), Blue (410-415nm), Sequence of Yellow (585-595nm) and Infra-red (820-830nm). This device is mainly made up of the base (main frame), the head (irradiator), and the lifting stand. The base unit contains power supply and control system. The user interface software allows the operator to access and control all device functions.

Summary parsed at:2026-06-01 05:56:04 UTC

Predicate devices

2

K192755 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K192755 as a predicate