K191881 is an FDA 510(k) clearance for the KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun. This device is classified as a Booth, Sun Tan (Class II - Special Controls, product code LEJ).
Submitted by Kbl GmbH (Dernbach, DE). The FDA issued a Cleared decision on October 28, 2019, 105 days after receiving the submission on July 15, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4635.
| 510(k) Number | K191881 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2019 |
| Decision Date | October 28, 2019 |
| Days to Decision | 105 days |
| Submission Type | Special |
| 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 |