K151400 is an FDA 510(k) clearance for the Ergoline, Sun Angel, Soltron, Sundash and Palm Beach Tan Sunlamp Products. This device is classified as a Booth, Sun Tan (Class II - Special Controls, product code LEJ).
Submitted by Jk Holding GmbH (Windhagen, DE). The FDA issued a Cleared decision on September 16, 2015, 113 days after receiving the submission on May 26, 2015.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635.
| 510(k) Number | K151400 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 2015 |
| Decision Date | September 16, 2015 |
| Days to Decision | 113 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LEJ - Booth, Sun Tan |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4635 |