K153291 is an FDA 510(k) clearance for the SICAT OPTISLEEP. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Sicat GmbH & Co. KG (Bonn, DE). The FDA issued a Cleared decision on March 31, 2016, 139 days after receiving the submission on November 13, 2015.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K153291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2015 |
| Decision Date | March 31, 2016 |
| Days to Decision | 139 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LRK - Device, Anti-snoring |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.5570 |