INTEGRE, MODEL LP581— 510(k) K080423

Name: FDA 510(k) clearance K080423
Creator: U.S. Food and Drug Administration
Published: 2008-03-11

Substantially Equivalent

Ellex Medical Pty, Ltd.

FDA 510(k) clearance K080423 for INTEGRE, MODEL LP581, Substantially Equivalent on 2008-03-11. Applicant: Ellex Medical Pty, Ltd.. Device class: 2.

Clearance details

Applicant: Ellex Medical Pty, Ltd.
Product code: Code HQF
Device class: Class 2
Regulation: 21 CFR 886.4390
Advisory panel: Ophthalmic
Date received: 2008-02-15
Decision date: 2008-03-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Adelaide, South Australia, AU

Download summary PDF View on FDA.gov ↗

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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.