# K192755: Soli-Lite LG4 Galileo

- Pathway: 510(k) (Traditional)
- Applicant: Silhouet-Tone Corporation
- Decided: Dec 20, 2019 after 81 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K943450 (1995). 132 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083183: Aklarus Phototherapy System, Hill Laboratories Co. (2009) Summary page 4.

## Most influential descendants
- K221083: Smartlux Mini (2022), 2 descendants of its own
- K233077: FlashHeal 2 (FlashHeal 2.0) (2024), 0 descendants of its own
- K231894: LED Spectrum therapy instrument (2023), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K192755
Methodology: https://510kreport.com/methodology