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VX130 Ophthalmic Diagnostic Device

by Luneau Sas

510(k) K162067

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK162067 Date24 Apr 2017ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HKX
Device Class
Class II
Regulation
21 CFR Part 886.1930
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VX130 is an ac-powered tonometer designed for ophthalmic diagnostic use. It integrates multiple diagnostic functions, including wavefront aberrometry, corneal topography, cataract screening, Scheimpflug pachymetry, and non-contact tonometry, to assess anterior segment anatomy and visual function in clinical settings.

Supplied as a reusable, Class II medical device, the VX130 is intended for use in ophthalmic examination rooms and clinics. It operates under FDA 510(k) clearance (K162067) and adheres to regulation 886.1930, with no third-party involvement. The device requires proper calibration and maintenance per manufacturer guidelines, though MRI safety and sterility specifications are not explicitly detailed in the available data.

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