K150175 is an FDA 510(k) clearance for the HeatLux Pro I. 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 March 31, 2015, 64 days after receiving the submission on January 26, 2015.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K150175 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 26, 2015 |
| Decision Date | March 31, 2015 |
| Days to Decision | 64 days |
| Submission Type | Special |
| 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 |