510(k) · Cleared
Recalled · Class II · 2021Lenstar, Model LS900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haag-Streit AG · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Oct 20, 2009 as substantially equivalent to K993357 (Carl Zeiss, Inc., 2000) and 3 other predicates after a 385-day review. Its family tree reaches back 4 generations to 1996. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 20, 2009
- Review
- 385 days
- Class
- Class II
- Product code
- HJO
- Recalls
- 3
- Predicates
- 4
Its longest line of descent runs back 4 generations to K955442 (1996). 18 ancestors in all, the oldest K781994 (1979). 14 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 3 generations backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- 2 generations backK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- 1 generation backK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- This deviceK082891 Lenstar, Model LS900Haag-Streit AG · 2009
- Descendant · cites it directly · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 2 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- Descendant · cites it directly · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
- Descendant · 2 generations on · 3 of its ownK170171 IOLMaster 700Carl Zeiss Meditec, AG · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK152311 Pentacam AXLOculus Optikgerate GmbH · 2016 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · cites it directly10descendants
- K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 2 generations on9descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · cites it directly4descendants
- K170171IOLMaster 700Carl Zeiss Meditec, AG · 2017 · 2 generations on3descendants
- K152311Pentacam AXLOculus Optikgerate GmbH · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −3 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| −2 | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| −1 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| 0 (this device) | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | — |
| +1 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| +2 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| +1 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
| +2 | K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017 | 1 |
| +3 | K152311 | Pentacam AXL | Oculus Optikgerate GmbH | 2016 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K993357 | IolmasterSummary page 2…MARKETED PREDICATE DEVICES Trade/Device Name: IOLMaster Applicant: Carl Zeiss Inc. 510(k) Premarket Notification number: K993357 Classification: Class II FDA Product Code: HJO - Biomicroscope, Slit Lamp, AC… | 2000 |
| * | K030393 | Optical Low Coherence Reflectometry (Olcr) PachymeterSummary page 2…Reflectometry Pachymeter (OLCR) Applicant: Haag-Streit AG 510(k) Premarket Notification number: K030393 Classification: Class II FDA Product Code: MXK - Device, Analysis, Anterior Segme… | 2003 |
| * | K032956 | Accusonic a-Scan Model, 24-4000Summary page 2…Accusonic A-Scan Model 24-4000 Applicant: Accutome 510(k) Premarket Notification number: K032956 Classification: Class II FDA Product Code: IYO - System, Imaging, Pulsed echo Est… | 2003 |
| * | K944616 | Keratron Corneal TopographerSummary page 2…2521877 Trade/Device Name: Keratron Applicant: Alliance Medical Marketing 510(k) Premarket Notification number: K944616 Classification: Class I FDA Product Code: HLQ-Keratoscope Establishment Registrat… | 1994 |
What descends from it? (14)
See all 145 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 |
|---|---|---|---|---|
| Apr 15, 2021 | Class II | Z-1560-2021 | Software design | Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI). |
| Jun 20, 2011 | Not classified | Z-2964-2011 | Software change control | A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000. |
| May 19, 2010 | Not classified | Z-1897-2010 | PMA | During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The current software installed allows the user… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K101182 (Carl Zeiss Meditec, AG, 2010) has gone furthest, with 10 descendants of its own.
- 2 other devices also cite its predicate K993357.
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. 2009, 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 LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures:
Axial eye length
Corneal thickness
Anterior chamber depth
Aqueous depth
Lens thickness
Radii of curvature of flat and steep meridian
Axis of the flat meridian
White to white distance
Pupil diameter
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082891 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082891: Lenstar, Model LS900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082891
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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