# K202221: VX650

- Pathway: 510(k) (Traditional)
- Applicant: Luneau Technology Operations
- Decided: Jan 29, 2021 after 176 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K941234 (1995). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162067: VX130 Ophthalmic Diagnostic Device, Luneau Sas (2017) Summary page 5.
- K180306: Nexy, Next Sight Srl (2018) Summary page 7.
- K101935: Centervue Digital Retinography System, Centervue S.P.A. (2010) Summary page 7.

## Indications for use
The VX650 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 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 cornea thickness map * Scheimpflug imaging * Anterior chamber imaging * Pupil Image * Image of the cornea relative to the iris » Automatic eye-fundus camera intended for taking digital images of a human retina without the use of a mydriatic agent

Source page: https://510kreport.com/device/K202221
Methodology: https://510kreport.com/methodology