K131259 is an FDA 510(k) clearance for the LASER-STIM. This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, Guangdong, CN). The FDA issued a Cleared decision on December 27, 2013, 239 days after receiving the submission on May 2, 2013.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K131259 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2013 |
| Decision Date | December 27, 2013 |
| Days to Decision | 239 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ILY — Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |