510(k) · Cleared
ClearedVX130 Ophthalmic Diagnostic Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Luneau Sas · HKX Tonometer, Ac-Powered
Cleared on Apr 24, 2017 as substantially equivalent to K143086 (Luneau Sas, 2015) and 1 other predicate after a 272-day review. Its family tree reaches back 4 generations to 1996. 1 later device descends from it.
- Decided
- Apr 24, 2017
- Review
- 272 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K955442 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 3 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 2 generations backK030719 Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003 · Recalled
- 1 generation backK143086 VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015
- This deviceK162067 VX130 Ophthalmic Diagnostic DeviceLuneau Sas · 2017
- Descendant · cites it directly · 0 of its ownK202221 VX650Luneau Technology Operations · 2021
Most influential descendants
Showing 1 of 1 · See all- K202221VX650Luneau Technology Operations · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −3 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −2 | K030719 | Pentacam Scheimpflug Camera | Oculus Optikgerate GmbH | 2003 | 1 |
| −1 | K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015 | — |
| 0 (this device) | K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017 | — |
| +1 | K202221 | VX650 | Luneau Technology Operations | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 HKX? 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 HKX device
- #1 K253039 Auto Kerato-Refracto Tonometer TRK-3 Omniascore 11.5 · 5 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K143086 | VX120 Ophthalmic Diagnostic DeviceSummary page 4…d to be substantially equivalent to the following currently marketed devices: . VX120 Ophthalmic Diagnostic Device Manufacturer: LUNEAU SAS FDA K143086 issued June 1, 2015. Product code: HKX . CM3910 ROTATING DOUBLE SCHEIMPFLUG CAMERA (Galilei G4) Manufac… | 2015 |
| * | K051940 | CM 3910 Rotating Double Scheimpflug CameraSummary page 4…CHEIMPFLUG CAMERA (Galilei G4) Manufacturer: SIS LTD. SURGICAL INSTRUMENT SYSTEMS Allmendstrasse 11 Port Bern, SWITZERLAND CH - 2562 FDA K051940 issued July 15, 2005. Product code: MXK The VX130 is equivalent to VX120 for tonometry and pachymetry functions… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202221 | VX650 | 2021 | 0 |
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 21 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K202221 (Luneau Technology Operations, 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K143086.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HKX
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HKX
290in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKX
No recall names HKX since 2007.
Adverse event reports per year · HKX
1in 2015
MAUDE reports naming product code HKX, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 3 | 290 | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162067: VX130 Ophthalmic Diagnostic Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162067
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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