510(k) · Cleared
ClearedGalilei G6 Lens Professional
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sis Ag, Surgical Instrument Systems · MXK Device, Analysis, Anterior Segment
Cleared on Jul 25, 2019 as substantially equivalent to K051940 (Sis Ltd., Surgical Instrument Systems, 2005) and 1 other predicate after a 303-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jul 25, 2019
- Review
- 303 days
- Class
- Class II
- Product code
- MXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K955442 (1996). 24 ancestors in all, the oldest K781994 (1979). No later device cites it as a predicate yet.
- Root · 8 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 7 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 6 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- 5 generations backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- 4 generations backK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- 3 generations backK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- 2 generations backK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- 1 generation backK152311 Pentacam AXLOculus Optikgerate GmbH · 2016 · Recalled
- This deviceK182659 Galilei G6 Lens ProfessionalSis Ag, Surgical Instrument Systems · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −7 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −6 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| −5 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| −4 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| −3 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| −2 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| −1 | K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016 | 3 |
| 0 (this device) | K182659 | Galilei G6 Lens Professional | Sis Ag, Surgical Instrument Systems | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MXK device
- #1 K251848 Pentacam® Cornea OCTscore 13.7 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051940 | CM 3910 Rotating Double Scheimpflug CameraSummary page 4…e: MXK, HJO Regulation Number: 886.1850 III. PREDICATE DEVICE The following two predicate devices were chosen: 1. Galilei G4 Dual Scheimpflug Analyzer (K051940) for topography/ tomography measurements only and 2. Pentacam® AXL (K152311) for topography/tomography as well as bio… | 2005 |
| * | K152311 | Pentacam AXLSummary page 4…g two predicate devices were chosen: 1. Galilei G4 Dual Scheimpflug Analyzer (K051940) for topography/ tomography measurements only and 2. Pentacam® AXL (K152311) for topography/tomography as well as biometry measurements The Galilei G6 Lens Professional is (in hardware and software… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 2.8 years on median.
- 6 of the 24 ancestors have a recall of any class.
- 1 other device also cites its predicate K051940.
How does its category compare?
All MXK devicesMXK Device, Analysis, Anterior Segment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MXK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MXK
Too few MXK 510(k)s in any year since 2007 to give a median.
Recalls per year · MXK
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MXK
1in 2025
MAUDE reports naming product code MXK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (148 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182659: Galilei G6 Lens Professional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182659
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026