K022104 is an FDA 510(k) clearance for the DERMAPAL, UVA 50HZ, UVA 60HZ, UVB BROAD BAND 50HZ, UVB BROAD BAND 60HZ,UVB NARROW BAND 50HZ, UVB NARROW BAND 60HZ. 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 September 10, 2002, 74 days after receiving the submission on June 28, 2002.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4630.
| 510(k) Number | K022104 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2002 |
| Decision Date | September 10, 2002 |
| Days to Decision | 74 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 |