K100378 is an FDA 510(k) clearance for the 1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4, 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 April 28, 2010, 71 days after receiving the submission on February 16, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K100378 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 16, 2010 |
| Decision Date | April 28, 2010 |
| Days to Decision | 71 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 |