K112016 is an FDA 510(k) clearance for the L-SER KO LAMP. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Ya-Man, Ltd. (Richmond, US). The FDA issued a Cleared decision on February 10, 2012, 211 days after receiving the submission on July 14, 2011.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K112016 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 14, 2011 |
| Decision Date | February 10, 2012 |
| Days to Decision | 211 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 |