510(k) · Cleared
ClearedVisx Customvue Slit Illuminator with Desktop Charger, Model CV SI-1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Visx, Incorporated · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Apr 5, 2005 as substantially equivalent to K954782 (Kowa Optimed, Inc., 1995) after a 106-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Apr 5, 2005
- Review
- 106 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954782 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK954782 Kowa Portable Slit Lamp SL-14 & SL-14BKowa Optimed, Inc. · 1995
- This deviceK043503 Visx Customvue Slit Illuminator with Desktop Charger, Model CV SI-1Visx, Incorporated · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954782 | Kowa Portable Slit Lamp SL-14 & SL-14B | Kowa Optimed, Inc. | 1995 | — |
| 0 (this device) | K043503 | Visx Customvue Slit Illuminator with Desktop Charger, Model CV SI-1 | Visx, Incorporated | 2005 | — |
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 HJO? 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 HJO device
- #1 K253834 Visuref 600score 13.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K954782 | Kowa Portable Slit Lamp SL-14 & SL-14BSummary page 1…alence is claimed based on the and its Portable Slit Lamp, as the predicate device (K954782), with its similar intended use, classification as a slit lamp, as defined in 21 CFR 886.1850.… | 1995 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K954782.
How does its category compare?
All HJO devicesHJO Biomicroscope, Slit-Lamp, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HJO
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HJO
232in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HJO
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HJO
20in 2025
MAUDE reports naming product code HJO, 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 | 1 |
| 2008 | 4 | 117 | 0 | 3 |
| 2009 | 3 | 91 | 0 | 3 |
| 2010 | 5 | 121 | 0 | 2 |
| 2011 | 2 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 7 |
| 2013 | 2 | — | 2 | 16 |
| 2014 | 10 | 196 | 0 | 4 |
| 2015 | 2 | — | 2 | 8 |
| 2016 | 5 | 243 | 0 | 15 |
| 2017 | 9 | 232 | 0 | 15 |
| 2018 | 2 | — | 1 | 11 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 1 | — | 0 | 18 |
| 2025 | 0 | — | 0 | 20 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The VISX CV SI-1 CustomVue Slit Illuminator is a diagnostic illumination device intended for use to inspect the structures of the anterior segment of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043503 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043503: Visx Customvue Slit Illuminator with Desktop Charger, Model CV SI-1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043503
Report an extraction error
Are you the manufacturer?
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