510(k) · Cleared

Cleared

Eye Sys Vista

K973756510(k) TraditionalCleared Nov 13, 199742-day reviewClass I21 CFR 886.1350

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Eyesys Technologies, Inc. · HLQ Keratoscope, Ac-Powered

Cleared on Nov 13, 1997 after a 42-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Nov 13, 1997
Review: 42 days
Class: Class I
Product code: HLQ
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K973756Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HLQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All HLQ devices

HLQ Keratoscope, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HLQ

FDA has decided no HLQ device since 2007.

Median 510(k) review, days · HLQ

Too few HLQ 510(k)s in any year since 2007 to give a median.

Recalls per year · HLQ

No recall names HLQ since 2007.

Adverse event reports per year · HLQ

1in 2017

2007high 1 (2017) · low 0 (2007)2025

MAUDE reports naming product code HLQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	1
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The EyeSys Vista has the same intended use as other corneal Analysis and Topography Systems. It specifically measures, records and displays corneal curvature in a non-invasive manner.

The EyeSys Vista will be operated by doctors and technicians in ophthalmic and optometric offices. Corneal topography analysis has become the standard of care for patient screening, pre and post operative corneal surgery documentation, corneal pathology determination and follow-up, as well as assisting in the fitting and follow-up of contact lenses.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973756 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973756: Eye Sys Vista.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973756

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026