PASCAL STREAMLINE PHOTOCOAGULATOR— 510(k) K100019

Substantially Equivalent

Optimedica Corporation

FDA 510(k) clearance K100019 for PASCAL STREAMLINE PHOTOCOAGULATOR, Substantially Equivalent on 2010-05-04. Applicant: Optimedica Corporation.

Clearance details

Applicant: Optimedica Corporation
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2010-01-05
Decision date: 2010-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQF

product code HQF

Injury: 166
Other: 1
Total: 167

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.