K111172 is an FDA 510(k) clearance for the 4 SERIES PHOTOTHERAPY UNIT MODEL 4 SERIES. 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 August 29, 2011, 125 days after receiving the submission on April 26, 2011.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K111172 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 2011 |
| Decision Date | August 29, 2011 |
| Days to Decision | 125 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 |