Identifiers
- 510(k) Number
- K192755 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Soli-Lite LG4 Galileo is a third-generation Light Emitting Diode (LED) photobiomodulation device designed for skin treatment. It delivers targeted light energy to stimulate cellular reactions, promoting collagen and elastin production by dermal fibroblasts. This process supports tissue repair and regeneration, addressing various dermatological conditions. The device operates within a defined wavelength spectrum to achieve therapeutic effects on the skin’s cellular level.
The Soli-Lite LG4 Galileo is supplied as a reusable medical device intended for professional use in clinical or aesthetic settings. It is not sterile and requires proper cleaning and maintenance between uses. The system is classified under product code GEX and has received FDA 510(k) clearance as substantially equivalent under the General, Plastic Surgery advisory committee. No specific MRI safety information is provided, and storage conditions must adhere to manufacturer guidelines to ensure device integrity and performance.
Frequently asked questions
What is the Soli-Lite LG4 Galileo used for?
The Soli-Lite LG4 Galileo is a third-generation LED photobiomodulation device designed to deliver targeted light energy to the skin. It promotes cellular reactions that stimulate collagen and elastin production by dermal fibroblasts, aiding tissue repair and regeneration. This makes it useful for addressing various dermatological conditions in professional clinical or aesthetic settings.
Is the Soli-Lite LG4 Galileo reusable or single-use?
The Soli-Lite LG4 Galileo is a reusable medical device intended for professional use. Since it is not sterile, it requires proper cleaning and maintenance between uses to ensure hygiene and performance. Always follow the manufacturer’s guidelines for cleaning and upkeep.
What are the key specifications and regulatory status of this device?
The Soli-Lite LG4 Galileo is classified under product code GEX and has received FDA 510(k) clearance as substantially equivalent under the General, Plastic Surgery advisory committee. The clearance was granted on December 20, 2019, following a review by the Specialty Devices (SU) committee. This device operates within a defined wavelength spectrum for therapeutic skin treatment.
How should the Soli-Lite LG4 Galileo be stored?
Storage conditions for the Soli-Lite LG4 Galileo must adhere to the manufacturer’s guidelines to maintain device integrity and performance. While specific storage instructions are not detailed in the provided data, it is critical to follow the manufacturer’s recommendations to ensure the device remains functional and safe for use.
Is there any information about MRI safety for this device?
No specific MRI safety information is provided for the Soli-Lite LG4 Galileo. If MRI compatibility is a concern, it is essential to consult the manufacturer’s documentation or contact their support team for detailed guidance before using the device in an MRI environment.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Soli-Lite - Silhouet-tone.ch, Soli-Lite - Silhouet-Tone, Silhouet-Tone Soli-Lite LG4 Galileo - clinicalbeautyusa.com, Soli-Lite LG4 Galileo LED Light Therapy - Greenlife
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192755 | Class II | Active |
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Manufacturer
- Manufacturer
- Silhouet-Tone Corporation
Sources (1)
- FDA 510(k) K192755 24 fields · synced Oct 5, 2026