510(k) · Cleared
ClearedVX120 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 Jun 1, 2015 as substantially equivalent to K093298 (Keeler Instruments, Inc., 2010) and 1 other predicate after a 217-day review. Its family tree reaches back 3 generations to 1996. 3 later devices descend from it.
- Decided
- Jun 1, 2015
- Review
- 217 days
- Class
- Class II
- Product code
- HKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K955442 (1996). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 2 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 1 generation backK030719 Pentacam Scheimpflug CameraOculus Optikgerate GmbH · 2003 · Recalled
- This deviceK143086 VX120 Ophthalmic Diagnostic DeviceLuneau Sas · 2015
- Descendant · cites it directly · 1 of its ownK162067 VX130 Ophthalmic Diagnostic DeviceLuneau Sas · 2017
- Descendant · 2 generations on · 0 of its ownK202221 VX650Luneau Technology Operations · 2021
- Descendant · cites it directly · 0 of its ownK201724 Pentacam AXL WaveOculus Optikgerate GmbH · 2020 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −2 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −1 | K030719 | Pentacam Scheimpflug Camera | Oculus Optikgerate GmbH | 2003 | 1 |
| 0 (this device) | K143086 | VX120 Ophthalmic Diagnostic Device | Luneau Sas | 2015 | — |
| +1 | K162067 | VX130 Ophthalmic Diagnostic Device | Luneau Sas | 2017 | — |
| +2 | K202221 | VX650 | Luneau Technology Operations | 2021 | — |
| +1 | K201724 | Pentacam AXL Wave | Oculus Optikgerate GmbH | 2020 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K093298 | Pulsair Intellipuff, Pulsair Desktop Model 2414-P-2001, 2417-P-2000Summary page 4…d to be substantially equivalent to the following currently marketed devices: Keeler Pulsair Desktop Tonometer Manufacturer: Keeler Ltd . FDA K093298 issued Dec 10, 2010. Product code: HKX Pentacam, Scheimplug camera Manufacturer: Oculus Optikgeraete GmbH,… | 2010 |
| * | K030719 | Pentacam Scheimpflug CameraSummary page 4…. FDA K093298 issued Dec 10, 2010. Product code: HKX Pentacam, Scheimplug camera Manufacturer: Oculus Optikgeraete GmbH, Germany FDA K030719 issued Sept 16, 2003. Product code: MXK The VX120 is equivalent for other functions not subject to 510(k) to the f… | 2003 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 19 years and passes through 4 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K162067 (Luneau Sas, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093298.
How does its category compare?
All HKX devicesHKX Tonometer, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 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.
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/K143086 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143086: VX120 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/K143086
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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