K222475 is an FDA 510(k) clearance for the SNOR LOCK. This device is classified as a Device, Anti-snoring (Class II - Special Controls, product code LRK).
Submitted by Solbaro Co., Ltd. (Gamgok-Myeon, Eumseong-Gun, KR). The FDA issued a Cleared decision on November 10, 2022, 86 days after receiving the submission on August 16, 2022.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.5570.
| 510(k) Number | K222475 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2022 |
| Decision Date | November 10, 2022 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| 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 |