SNOR LOCK— 510(k) K222475

Substantially Equivalent

Solbaro Co., Ltd.

FDA 510(k) clearance K222475 for SNOR LOCK, Substantially Equivalent on 2022-11-10. Applicant: Solbaro Co., Ltd..

Clearance details

Applicant: Solbaro Co., Ltd.
Product code: Code LRK
Advisory panel: Dental
Date received: 2022-08-16
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gamgok-Myeon, Eumseong-Gun, KR

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.