K153399 is an FDA 510(k) clearance for the LightStim Professional LED Bed. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Led Intellectual Properties, LLC (Irvine, US). The FDA issued a Cleared decision on July 5, 2016, 224 days after receiving the submission on November 24, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K153399 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 24, 2015 |
| Decision Date | July 05, 2016 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | ILY — Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |