K083580 is an FDA 510(k) clearance for the ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Led Intellectual Properties, LLC (Knoxville, US). The FDA issued a Cleared decision on June 22, 2009, 201 days after receiving the submission on December 3, 2008.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K083580 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2008 |
| Decision Date | June 22, 2009 |
| Days to Decision | 201 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 |