K220330 is an FDA 510(k) clearance for the Soundly Anti Snoring Device. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Greystone Ip, Ltd. (Belfast, IE). The FDA issued a Cleared decision on September 8, 2022, 216 days after receiving the submission on February 4, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K220330 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2022 |
| Decision Date | September 08, 2022 |
| Days to Decision | 216 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 |