K113668 is an FDA 510(k) clearance for the HEALITE II SYSTEM. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Lutronic Corporation (Trevose, US). The FDA issued a Cleared decision on June 19, 2012, 189 days after receiving the submission on December 13, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K113668 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 2011 |
| Decision Date | June 19, 2012 |
| Days to Decision | 189 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 |