510(k) · Cleared
ClearedVisulux
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Feb 23, 2017 as substantially equivalent to K133476 (Carl Zeiss Meditec, AG, 2014) after a 258-day review. Its family tree reaches back 7 generations to 1990.
- Decided
- Feb 23, 2017
- Review
- 258 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896095 (1990). 18 ancestors in all, the oldest K862004 (1986). No later device cites it as a predicate yet.
- Root · 7 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 6 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 5 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 4 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 3 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 2 generations backK110129 Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011
- 1 generation backK133476 Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG · 2014
- This deviceK161607 VisuluxCarl Zeiss Meditec, AG · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −6 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −5 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −4 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −3 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −2 | K110129 | Righton Zoom Slit Lamp Microscope with Photo Option | Rightmedical Products, LLC | 2011 | — |
| −1 | K133476 | Slit Lamps with SL Cam 5.0 Digital Imaging Solution | Carl Zeiss Meditec, AG | 2014 | — |
| 0 (this device) | K161607 | Visulux | Carl Zeiss Meditec, AG | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 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 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 |
|---|---|---|---|
| * | K133476 | Slit Lamps with SL Cam 5.0 Digital Imaging SolutionSummary page 4…/Proprietary Name: VISULUX Predicate Device SL 115 Classic slit lamp Manufactured by Carl Zeiss Meditec Predicate 510(k) Number K133476 Page 1 DEVICE DESCRIPTION (21 CFR §807… | 2014 |
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 27 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- None of the 18 ancestors has a recall.
- 2 other devices also cite its predicate K133476.
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. 2017, this device’s year, is highlighted.
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 fiber slit illuminator is indicated for use as an alternative illumination system to the surgical microscope in ophthalmic microsurgery for procedures on the anterior and posterior segments of the eye. The fiber slit illuminator is not equipped with a light source, but uses the light transferred from the microscope by a light guide.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161607 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161607: Visulux.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161607
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