Remvia NightGuard— 510(k) K250743

Substantially Equivalent

Remvia

FDA 510(k) clearance K250743 for Remvia NightGuard, Substantially Equivalent on 2025-12-05. Applicant: Remvia.

Clearance details

Applicant: Remvia
Product code: Code MQC
Advisory panel: Unknown
Date received: 2025-03-11
Decision date: 2025-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MQC

product code MQC

Injury: 377
Total: 377

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.