BAYLAB 3-Ply Surgical Mask (BEACON I)— 510(k) K212302

Substantially Equivalent

Baylab USA, LLC

FDA 510(k) clearance K212302 for BAYLAB 3-Ply Surgical Mask (BEACON I), Substantially Equivalent on 2021-12-07. Applicant: Baylab USA, LLC.

Clearance details

Applicant: Baylab USA, LLC
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2021-07-23
Decision date: 2021-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dallas, 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.