Surgical 3D Mask— 510(k) K203565

Substantially Equivalent

Inno Lifecare

FDA 510(k) clearance K203565 for Surgical 3D Mask, Substantially Equivalent on 2021-10-19. Applicant: Inno Lifecare.

Clearance details

Applicant: Inno Lifecare
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2020-12-07
Decision date: 2021-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Coquitlam, CA

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.