K110912 is an FDA 510(k) clearance for the SMART TOUCH UVTHERAPY MULTIPLE MACHINE, 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 October 20, 2011, 202 days after receiving the submission on April 1, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K110912 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 01, 2011 |
| Decision Date | October 20, 2011 |
| Days to Decision | 202 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 |