K061080 is an FDA 510(k) clearance for the IR PRO 250. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Lhasa Oms, Inc. (Weymouth, US). The FDA issued a Cleared decision on June 14, 2006, 57 days after receiving the submission on April 18, 2006.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K061080 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 18, 2006 |
| Decision Date | June 14, 2006 |
| Days to Decision | 57 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 |