Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)— 510(k) K180305

Substantially Equivalent

Aquilabs Us, LLC

FDA 510(k) clearance K180305 for Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC), Substantially Equivalent on 2018-04-13. Applicant: Aquilabs Us, LLC.

Clearance details

Applicant: Aquilabs Us, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2018-02-02
Decision date: 2018-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medley, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.