K233811 is an FDA 510(k) clearance for the DT Controlled Phototherapy Equipment. This device is classified as a Light, Ultraviolet, Dermatological (Class II - Special Controls, product code FTC).
Submitted by Daavlin Distributing Co. (Bryan, US). The FDA issued a Cleared decision on December 13, 2023, 14 days after receiving the submission on November 29, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K233811 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 29, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 14 days |
| Submission Type | Special |
| 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 |