Manufacturer
Silhouet-Tone CorporationSoli-Lite LG4 Galileo
Country / Region:Canada (CA)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K192755
- Device name
- Soli-Lite LG4 Galileo
- Company
- Silhouet-Tone Corporation
- 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
2Cited as predicate
1Smartlux Mini
1 submission cite K192755 as a predicate
