K200971 is an FDA 510(k) clearance for the 308nm Excimer System. This device is classified as a Light, Ultraviolet, Dermatological (Class II - Special Controls, product code FTC).
Submitted by Xuzhou Kernel Medical Equipment Co., Ltd. (Xuzhou, CN). The FDA issued a Cleared decision on December 15, 2020, 246 days after receiving the submission on April 13, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K200971 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2020 |
| Decision Date | December 15, 2020 |
| Days to Decision | 246 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 |