AIRVIT MODEL 8500— 510(k) K843594

Name: FDA 510(k) clearance K843594
Creator: U.S. Food and Drug Administration
Published: 1985-04-11

Substantially Equivalent

Lasermed Corp.

FDA 510(k) clearance K843594 for AIRVIT MODEL 8500, Substantially Equivalent on 1985-04-11. Applicant: Lasermed Corp.. Device class: 2.

Clearance details

Applicant: Lasermed Corp.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1984-09-12
Decision date: 1985-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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.