IRIS MEDICAL IQ 810 PHOTOCOAGULATOR— 510(k) K040209

Substantially Equivalent

Iridex Corp

FDA 510(k) clearance K040209 for IRIS MEDICAL IQ 810 PHOTOCOAGULATOR, Substantially Equivalent on 2004-09-20. Applicant: Iridex Corp.

Clearance details

Applicant: Iridex Corp
Product code: Code HQF
Advisory panel: Ophthalmic
Date received: 2004-01-30
Decision date: 2004-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
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.