Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)— 510(k) K230228

Substantially Equivalent

Iridex Corporation

FDA 510(k) clearance K230228 for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models), Substantially Equivalent on 2023-02-23. Applicant: Iridex Corporation.

Clearance details

Applicant: Iridex Corporation
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2023-01-27
Decision date: 2023-02-23
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.