# K182659: Galilei G6 Lens Professional

- Pathway: 510(k) (Traditional)
- Applicant: Sis Ag, Surgical Instrument Systems
- Decided: Jul 25, 2019 after 303 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- 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 K955442 (1996). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051940: CM 3910 Rotating Double Scheimpflug Camera, Sis Ltd., Surgical Instrument Systems (2005) Summary page 4.
- K152311: Pentacam AXL, Oculus Optikgerate GmbH (2016) Summary page 4.

## Indications for use
The Galilei G6 Lens Professional) is designed to take images of the anterior segment of the eye, which includes cornea, iris, pupil, anterior chamber, and crystalline lens. To evaluate: • Corneal shape • Pachymetry (corneal thickness) • Position of the cornea relative to iris and lens • Anterior and posterior opacity • Anterior chamber angle • Anterior chamber depth • Volume of the anterior chamber • White-to-white distance • Pupil size • Condition and position of implants (e.g. IOL, phakic IOLs, intracorneal rings) • Location of cataracts (nuclear, sub capsular and or cortical), using cross slit imaging with densitometry • Condition of the lens (opaque crystalline lens) • Lens shape • Crystalline lens thickness The Galilei G6 Lens Professional is designed to additionally evaluate: • Axial length The Galilei G6 Lens Professional) also performs calculations to assist physicians in determining the power of the intraocular lens for implantation.

Source page: https://510kreport.com/device/K182659
Methodology: https://510kreport.com/methodology