K180555 is an FDA 510(k) clearance for the Ergoline Prestige 1600 Hybrid Performance. 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 October 11, 2018, 224 days after receiving the submission on March 1, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635.
| 510(k) Number | K180555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2018 |
| Decision Date | October 11, 2018 |
| Days to Decision | 224 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 |