Humask Pro Vision, Humask Pro Vision 3000— 510(k) K222551

Substantially Equivalent

Entreprise Premont, Inc.

FDA 510(k) clearance K222551 for Humask Pro Vision, Humask Pro Vision 3000, Substantially Equivalent on 2022-11-10. Applicant: Entreprise Premont, Inc..

Clearance details

Applicant: Entreprise Premont, Inc.
Product code: Code FXX
Advisory panel: General, Plastic Surgery
Date received: 2022-08-23
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Louiseville, 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.