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

Name: FDA 510(k) clearance K842504
Creator: U.S. Food and Drug Administration
Published: 1984-10-01

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. Device class: 3.

Clearance details

Applicant: American Medical Optics
Product code: Code HQL
Device class: Class 3
Regulation: 21 CFR 886.3600
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 ↗

Recent devices under product code HQL

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K914311 — CHIROFLEX II LENS MICROSERT(TM)1992-01-27
K913626 — SOFTRANS INJECTOR1991-12-18
K842892 — NIDEK DIGITAL KERATOMETER1984-10-05
K771933 — CILCO ANTERIOR CHAMBER LENS1978-01-26

More clearances from American Medical Optics

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K860001 — BARRAQUER-KRUMEICH REFRACTIVE SET1986-02-04
K851263 — AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP1985-05-01
K851264 — AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS1985-05-01
K851262 — AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA1985-04-30
K844150 — MEDICAL OPTICS PHACOEMULSIFICATION KIT1984-12-11

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.