K152087 is an FDA 510(k) clearance for the HeatLux Pro II. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Home Skinovations , Ltd. (Yokneam, IL). The FDA issued a Cleared decision on July 29, 2016, 368 days after receiving the submission on July 27, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K152087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2015 |
| Decision Date | July 29, 2016 |
| Days to Decision | 368 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 |