510(k) · Cleared
Recalled · Class II · 2018IOLMaster 700
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 Apr 6, 2017 as substantially equivalent to K143275 (Carl Zeiss Meditec, Inc., 2015) after a 77-day review. Its family tree reaches back 9 generations to 1990. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 6, 2017
- Review
- 77 days
- Class
- Class II
- Product code
- HJO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K896095 (1990). 39 ancestors in all, the oldest K781994 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 5 generations between
- 3 generations backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- 2 generations backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- 1 generation backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- This deviceK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017
- Descendant · cites it directly · 1 of its ownK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK252633 Unity DX (Udx)Cylite Pty., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK191051 ARGOSSantec Corporation · 2019
Show all 9 generations
- Root · 9 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 8 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 7 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 6 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 5 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 4 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 3 generations backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- 2 generations backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- 1 generation backK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- This deviceK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017
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 |
|---|---|---|---|---|---|
| −9 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −8 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −7 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −6 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −5 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −4 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −3 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| −2 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| −1 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| 0 (this device) | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | — |
| +1 | K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018 | 1 |
| +2 | K252633 | Unity DX (Udx) | Cylite Pty., Ltd. | 2025 | — |
| +1 | K191051 | ARGOS | Santec Corporation | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K143275 | IOLMaster700Summary page 4…Ophthalmology Product Code: HJO - AC-powered slitlamp biomicroscope. Predicate Device: Carl Zeiss Meditec AG IOLMASTER 700 K143275 Product Code: HJO - AC-powered slitlamp biomicroscope. Indications for Use: The indications for use are identical between the s… | 2015 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2018 | Class II | Z-0108-2019 | Employee error | Calibration setting was incorrectly entered during manufacturing causing the optical coherence tomography (OCT) to obtain the incorrect two-dimensional images of ocular structures of the anterior and posterior segments of the eye. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 8 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 39 ancestors have a recall of any class.
- Of its descendants, K173771 (Carl Zeiss Meditec, AG, 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K143275.
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 IOLMaster 700 is intended for biometric measurements and visualization of ocular structures. The measurements and visualization assist in the determination of the appropriate power and type of intraocular lens. The IOLMaster 700 measures:
• Lens thickness
• Corneal curvature and thickness
• Axial length
• Anterior chamber depth
• Pupil diameter
• White-to-white distance (WTW)
For visualization, the IOLMaster 700 employs optical coherence tomography (OCT) to obtain two-dimensional images of ocular structures of the anterior and posterior segments of the eye.
The Reference Image functionality is intended for use as a preoperative and postoperative image capture tool.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170171 · printed Nov 4, 2026
Cite this page
510(k) Report. “K170171: IOLMaster 700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K170171
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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