K120582 is an FDA 510(k) clearance for the HEATLUX. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Home Skinovations , Ltd. (Yokneam Illit, IL). The FDA issued a Cleared decision on July 6, 2012, 130 days after receiving the submission on February 27, 2012.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K120582 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2012 |
| Decision Date | July 06, 2012 |
| Days to Decision | 130 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 |