Iridex 810 Laser— 510(k) K213592

Substantially Equivalent

Iridex Corporation

FDA 510(k) clearance K213592 for Iridex 810 Laser, Substantially Equivalent on 2022-03-23. Applicant: Iridex Corporation.

Clearance details

Applicant: Iridex Corporation
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2021-11-12
Decision date: 2022-03-23
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.