OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER— 510(k) K090206

Substantially Equivalent

Oculus Innovative Sciences, Inc.

FDA 510(k) clearance K090206 for OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER, Substantially Equivalent on 2009-06-02. Applicant: Oculus Innovative Sciences, Inc..

Clearance details

Applicant: Oculus Innovative Sciences, Inc.
Product code: Code FRO
Advisory panel: Unknown
Date received: 2009-01-28
Decision date: 2009-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Petaluma, CA, 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.