510(k) · Cleared
ClearedIOLMaster700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Jul 10, 2015 as substantially equivalent to K122418 (Carl Zeiss Meditec, AG, 2013) and 2 other predicates after a 238-day review. Its family tree reaches back 8 generations to 1990. 4 later devices descend from it.
- Decided
- Jul 10, 2015
- Review
- 238 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K896095 (1990). 38 ancestors in all, the oldest K781994 (1979). 4 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK896095 Images-on-Call Teleradiology SystemDevices & Services Co. · 1990
- 7 generations backK962699 Radworks Medical Imaging SoftwareApplicare Medical Imaging, B.V. · 1996
- 6 generations backK982862 Radworks Medical Imaging Software with Quality Control ModuleApplicare Medical Imaging, B.V. · 1998
- 5 generations backK012093 Aetmed Image Processing SoftwareAetmed, S.P.A. · 2001
- 4 generations backK013694 Nidek Advanced Vision Information System (Navis)Nidek, Inc. · 2002
- 3 generations backK082364 Imagenet Professional PC Software System or Imagenet Professional…Topcon Corp. · 2008
- 2 generations backK101861 Truevision 3D Visualization and Guidance SystemTruevision Systems, Incorporated · 2010
- 1 generation backK141068 Zeiss Cataract Suite MarkerlessCarl Zeiss Meditec, AG · 2014
- This deviceK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK173771 IOLMaster 700Carl Zeiss Meditec, AG · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK252633 Unity DX (Udx)Cylite Pty., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK191051 ARGOSSantec Corporation · 2019
Most influential descendants
Showing 4 of 4 · See all- K170171IOLMaster 700Carl Zeiss Meditec, AG · 2017 · cites it directly3descendants
- K173771IOLMaster 700Carl Zeiss Meditec, AG · 2018 · 2 generations on1descendant
- K252633Unity DX (Udx)Cylite Pty., Ltd. · 2025 · 3 generations on0descendants
- K191051ARGOSSantec Corporation · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896095 | Images-on-Call Teleradiology System | Devices & Services Co. | 1990 | — |
| −7 | K962699 | Radworks Medical Imaging Software | Applicare Medical Imaging, B.V. | 1996 | — |
| −6 | K982862 | Radworks Medical Imaging Software with Quality Control Module | Applicare Medical Imaging, B.V. | 1998 | — |
| −5 | K012093 | Aetmed Image Processing Software | Aetmed, S.P.A. | 2001 | — |
| −4 | K013694 | Nidek Advanced Vision Information System (Navis) | Nidek, Inc. | 2002 | — |
| −3 | K082364 | Imagenet Professional PC Software System or Imagenet Professional, or Imagenet… | Topcon Corp. | 2008 | — |
| −2 | K101861 | Truevision 3D Visualization and Guidance System | Truevision Systems, Incorporated | 2010 | — |
| −1 | K141068 | Zeiss Cataract Suite Markerless | Carl Zeiss Meditec, AG | 2014 | — |
| 0 (this device) | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| +1 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
| +2 | K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018 | 1 |
| +3 | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 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? (3)
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 |
|---|---|---|---|
| * | K122418 | Iolmaster 500Summary page 4…Master 700 is similar in function and application and is used in the preparation phase of cataract surgery as the following predicate devices: • the IOLMaster 500 (K122418) - the primary predicate as it has the most similar intended use and characteristics, • the Lenstar LS 900 (K082891)… | 2013 |
| * | K082891 | Lenstar, Model LS900Summary page 4…cate devices: • the IOLMaster 500 (K122418) - the primary predicate as it has the most similar intended use and characteristics, • the Lenstar LS 900 (K082891) is an additional (secondary) predicate to support the two new measurements featured on the IOLMaster 700, • additio… | 2009 |
| * | K141068 | Zeiss Cataract Suite MarkerlessSummary page 4…edicate to support the two new measurements featured on the IOLMaster 700, • additionally, the IOLMaster 500 as part of the ZEISS Cataract Suite markerless (K141068) for the Reference Imaging feature. Page 1 of 13… | 2014 |
| † | K051789 | Visante Oct | 2005 |
What descends from it? (4)
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 25 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 5 of the 38 ancestors have a recall of any class.
- Of its descendants, K170171 (Carl Zeiss Meditec, AG, 2017) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K122418.
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. 2015, 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: x Lens thickness x Corneal curvature and thickness x Axial length x Anterior chamber depth x Pupil diameter x White-to-white distance (WTW) For visualization, the IOLMaster 700 employs optical coherence tomography…
Read the full statement (98 words)
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:
x Lens thickness
x Corneal curvature and thickness
x Axial length
x Anterior chamber depth
x Pupil diameter
x 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/K143275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143275: IOLMaster700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143275
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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