K200971 is an FDA 510(k) clearance for the 308nm Excimer System, 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 review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K200971 FDA.gov |
| FDA Decision | Cleared 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 |