# K162067: VX130 Ophthalmic Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Luneau Sas
- Decided: Apr 24, 2017 after 272 days
- Product code: HKX (Tonometer, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955442 (1996). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143086: VX120 Ophthalmic Diagnostic Device, Luneau Sas (2015) Summary page 4.
- K051940: CM 3910 Rotating Double Scheimpflug Camera, Sis Ltd., Surgical Instrument Systems (2005) Summary page 4.

## Most influential descendants
- K202221: VX650 (2021), 0 descendants of its own

## Indications for use
The VX130 is a multi-function diagnostic device combining wavefront aberometer, corneal topographer, retro-illuminator, tonometer and pachymeter, indicated for: Measuring the refraction of the eye giving both lower and higher order aberrations Measurement of the shape of the cornea Retro-illumination imaging of the eye Measuring the intraocular pressure without contacting the eye for glaucoma evaluation. Photographing the eye and taking images of the eye to evaluate the thickness of the central cornea. Full corneal thickness map. Scheimpflug imaging. Anterior chamber imaging. Pupil image. Image of the cornea relative to the iris.

Source page: https://510kreport.com/device/K162067
Methodology: https://510kreport.com/methodology