WELLTRUST WT-III Mask with Flat Earloop— 510(k) K211751

Substantially Equivalent

Lonestar Meadows, LLC

FDA 510(k) clearance K211751 for WELLTRUST WT-III Mask with Flat Earloop, Substantially Equivalent on 2021-09-17. Applicant: Lonestar Meadows, LLC.

Clearance details

Applicant: Lonestar Meadows, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-06-07
Decision date: 2021-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FXX

product code FXX

Injury: 137
Total: 137

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.