K181455 is an FDA 510(k) clearance for the ProSun sunlamp products, Luxura sunlamp products. This device is classified as a Booth, Sun Tan (Class II - Special Controls, product code LEJ).
Submitted by Prosun International, LLC (Saint Petersburg, US). The FDA issued a Cleared decision on September 10, 2018, 98 days after receiving the submission on June 4, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635.
| 510(k) Number | K181455 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 04, 2018 |
| Decision Date | September 10, 2018 |
| Days to Decision | 98 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 |