K132643 is an FDA 510(k) clearance for the UV PHOTOTHERAPY. This device is classified as a Light, Ultraviolet, Dermatological (Class II - Special Controls, product code FTC).
Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 30, 2014, 157 days after receiving the submission on August 26, 2013.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K132643 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2013 |
| Decision Date | January 30, 2014 |
| Days to Decision | 157 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | FTC - Light, Ultraviolet, Dermatological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4630 |