Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)— 510(k) K223132

Substantially Equivalent

Iridex Corporation

FDA 510(k) clearance K223132 for Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models), Substantially Equivalent on 2022-11-09. Applicant: Iridex Corporation.

Clearance details

Applicant: Iridex Corporation
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2022-10-03
Decision date: 2022-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, 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.