AMER. MEDICAL OPTICS DIGITAL KERATO-— 510(k) K842504

Substantially Equivalent

American Medical Optics

FDA 510(k) clearance K842504 for AMER. MEDICAL OPTICS DIGITAL KERATO-, Substantially Equivalent on 1984-10-01. Applicant: American Medical Optics.

Clearance details

Applicant: American Medical Optics
Product code: Code HQL
Advisory panel: Ophthalmic
Date received: 1984-06-26
Decision date: 1984-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HQL

product code HQL

Injury: 7,145
Malfunction: 15,684
Other: 5
Total: 22,834

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.