VX120 Ophthalmic Diagnostic Device

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

510(k) Number

K143086 ↗

FDA Product Code

HKX

Device Class

Class II

Regulation

21 CFR Part 886.1930

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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• What is the VX120 Ophthalmic Diagnostic Device used for?

  The VX120 is used for anterior segment analysis and vision screening, integrating five diagnostic functions: wavefront aberrometry for refraction and aberrations, corneal topography for keratometry and shape assessment, retro-illumination for detecting ocular opacities, Scheimpflug imaging for pachymetry, and air-puff tonometry for measuring intraocular pressure.

• Is the VX120 sterile or single-use?

  The VX120 is not sterile and is not intended for single use; it is a reusable, AC-powered system designed for repeated use in clinical settings, provided it undergoes appropriate cleaning and disinfection procedures between patients.

• How is the VX120 supplied and powered?

  The VX120 is supplied as a desk-mounted, reusable system that operates on AC power, intended for fixed installation in clinical ophthalmic environments such as clinics or offices where routine diagnostic testing is performed.

• What regulatory pathway was used for the VX120?

  The VX120 received FDA 510(k) clearance under submission number K143086, demonstrating substantial equivalence to a legally marketed predicate device, and is classified as a Class II medical device under regulation 886.1930 with product code HKX.

• What measurements does the VX120 perform?

  The VX120 performs five key measurements: wavefront aberrometry for refraction and optical aberrations, Placido disk-based corneal topography for corneal shape and keratometry, retro-illumination for visualization of lens and corneal opacities, Scheimpflug imaging for corneal pachymetry (thickness), and air-puff non-contact tonometry for intraocular pressure assessment.