# K143086: VX120 Ophthalmic Diagnostic Device

- Pathway: 510(k) (Traditional)
- Applicant: Luneau Sas
- Decided: Jun 1, 2015 after 217 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: 3 generations back to K955442 (1996). 6 ancestors in all.
3 later devices descend from it; 2 cite 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)
- K093298: Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000, Keeler Instruments, Inc. (2010) Summary page 4.
- K030719: Pentacam Scheimpflug Camera, Oculus Optikgerate GmbH (2003) Summary page 4.

## Most influential descendants
- K162067: VX130 Ophthalmic Diagnostic Device (2017), 1 descendant of its own
- K202221: VX650 (2021), 0 descendants of its own
- K201724: Pentacam AXL Wave (2020), 0 descendants of its own

## Indications for use
The VX120 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 Measuring the shape of the comea 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 cornea.

Source page: https://510kreport.com/device/K143086
Methodology: https://510kreport.com/methodology