K073587 is an FDA 510(k) clearance for the DERMAPAL WITH DIGITAL TIMER, 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 January 18, 2008, 29 days after receiving the submission on December 20, 2007. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K073587 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 2007 |
| Decision Date | January 18, 2008 |
| Days to Decision | 29 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 |