K241293
- 510(k) number
- K241293
- Device name
- LED Light Therapy Device, ELIXIR MD
- Applicant
- Yassen Wellness, LLC CA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-07-08
- Date received
- 2024-05-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K241293.pdf
Official FDA record: K241293
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.