Keeler Vantage Indirect Ophthalmoscope

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K942104 ↗

FDA Product Code

HLI

Device Class

Class II

Regulation

21 CFR Part 886.1570

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K841293 Active Cleared 9 May 1984

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  FDA 510(k) K841292 Active Cleared 9 May 1984

See all devices from Keeler Instruments, Inc. →

• What is the Keeler Vantage Indirect Ophthalmoscope used for?

  The Keeler Vantage Indirect Ophthalmoscope is a binocular device used for diagnostic examination of the eye, providing high-quality optics with automatic stereopsis and LED illumination for clear retinal views.

• How is the Keeler Vantage Indirect Ophthalmoscope supplied?

  This device is supplied as a head-worn instrument manufactured by Keeler Instruments, Inc. It is designed for comfortable hands-free use during ophthalmic examinations.

• What is the regulatory status of the Keeler Vantage Indirect Ophthalmoscope?

  The device has received FDA 510(k) clearance as substantially equivalent under product code HLI for ophthalmic use. It is classified as Class II and is not indicated for MRI safety.

• Is the Keeler Vantage Indirect Ophthalmoscope reusable or single-use?

  The device is designed for multiple uses as it is a head-worn instrument intended for repeated diagnostic examinations in clinical settings.