Iridex 810 Laser— 510(k) K213592

Name: FDA 510(k) clearance K213592
Creator: U.S. Food and Drug Administration
Published: 2022-03-23

Substantially Equivalent

Iridex Corporation

FDA 510(k) clearance K213592 for Iridex 810 Laser, Substantially Equivalent on 2022-03-23. Applicant: Iridex Corporation. Device class: 2.

Clearance details

Applicant: Iridex Corporation
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
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 ↗

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More clearances from Iridex Corporation

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K230228 — Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)2023-02-23
K223132 — Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)2022-11-09
K202760 — Iridex 810 Laser2020-10-21
K181662 — Iridex TruFocus LIO Premiere2018-09-05
K170718 — Iridex TruFocus LIO Premiere2017-05-03

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.