510(k) K153389 ยท ILY Lamp, Infrared, Therapeutic Heating
Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
| Applicant | In Light Wellness Systems, Inc., Albuquerque NM, US |
| Decision | Substantially Equivalent, Mar 30, 2016 |
| Received | Nov 23, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153389
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2019 | Inlightened Partners LLC inLight Medical LED Pads used with Polychromatic light technology system Terminated |
ILY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.