Data / Medical devices / United States / Elixir MD Inc
Elixir MD Inc: FDA-registered device maker in Irvine, CA, United States, 1 510(k) clearance
Elixir MD Inc is registered with the FDA (registration 3038372243) in Irvine, CA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 8, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3038372243
- Address
- 17700 Laguna Canyon Road Suite 150, Irvine, CA, United States, 92618
- Owner or operator
- ELIXIR MD Inc (10093317)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- April 29, 2025
- Registered through
- 2026
- Brand names listed
- ELIXIR MD
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 8, 2024 | K241293 | LED Light Therapy Device, ELIXIR MD | GEX | Substantially Equivalent | Yassen Wellness, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.