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
