Precision Vision

Company overview

Precision Vision, Inc. manufactures vision-testing products for ophthalmology, optometry, clinical trials and research. Founded in 1965, it operates from Woodstock, Illinois.

Its documented products include Sloan-letter ETDRS visual-acuity charts and LED illuminator cabinets, alongside additional reading, contrast-sensitivity and pediatric testing tools. The company also distributes other manufacturers’ ophthalmic equipment; those catalog listings are not treated as proprietary Precision Vision devices.

The company reports manufacturing under an ISO 13485:2016 quality system. FDA documentation independently identifies Precision Vision ETDRS charts as a reference device; that reference is not a clearance issued to Precision Vision.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA lists conventional visual-acuity charts under product code HOX, 21 CFR 886.1150, as Class I and 510(k)-exempt, subject to applicable limitations. Exemption is distinct from FDA clearance or approval. ^[6]

The FDA-hosted summary for Vimetrics K100095 identifies Precision Vision ETDRS charts and a lighted cabinet as the predicate comparison. K100095 is not a Precision Vision clearance and is excluded from this company’s clearance count. ^[5]

The reviewed evidence does not establish a complete model-specific regulatory inventory for cabinets or other catalog products.

Regulatory snapshot How to read this snapshot

U.S. FDA

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510(k) clearances

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De Novo grants

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PMA approvals

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Recall events

Latest recorded source review: 2026-10-28.

Commercial portfolio snapshot

Documented commercial product families.

Visual-acuity testing

ETDRS visual-acuity charts ↗

Standardized Sloan-letter charts used to measure visual acuity in clinical examinations and research. ^[4][6][5]

Exemption documented

Listed by the company; configurations and market availability vary.

Vision-testing equipment

LED ETDRS illuminator cabinets ↗

Illuminated cabinets that hold compatible ETDRS charts and provide controlled lighting for visual-acuity testing. ^[3]

Marketed · regulatory scope varies

Listed by the company; configurations and market availability vary.

Commercial development

The official careers page listed no open positions during this review and invited applications for future roles. That statement applies to the reviewed page, rather than proving the company is not hiring elsewhere. ^[2]