K143043 is an FDA 510(k) clearance for the Tanning Lamp. This device is classified as a Booth, Sun Tan (Class II - Special Controls, product code LEJ).
Submitted by Unilam Co., Ltd. (Ulsan Gwangyeogsi, KR). The FDA issued a Cleared decision on April 2, 2015, 162 days after receiving the submission on October 22, 2014.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635.
| 510(k) Number | K143043 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 22, 2014 |
| Decision Date | April 02, 2015 |
| Days to Decision | 162 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 |