Device details
FDA 510(k) registration fields
- K number
- K241293
- Device name
- LED Light Therapy Device, ELIXIR MD™
- Company
- Yassen Wellness, LLC
- Country / region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-05-08
- Decision date
- 2024-07-08
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Pigment treatmentAcne treatmentSkin tighteningOther
- Primary application
- Acne treatment
- Classification source
- AI classified
