510(k) · Cleared
ClearedDocumenting Laser Slit Lamp, DP 2010
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Nov 19, 2001 as substantially equivalent to K930518 (Talia Technology, Ltd., 1994) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1996. 18 later devices descend from it.
- Decided
- Nov 19, 2001
- Review
- 84 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955442 (1996). 4 ancestors in all, the oldest K930518 (1994). 18 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK955442 Kowa SC-1200 Photo Slit Lamp SystemKowa Optimed, Inc. · 1996
- 1 generation backK991284 Anterior Eye-Segment Analysis SystemNidek, Inc. · 1999
- This deviceK012873 Documenting Laser Slit Lamp, DP 2010Bausch & Lomb, Inc. · 2001
- Descendant · cites it directly · 16 of its ownK030393 Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003
- Descendant · 2 generations on · 14 of its ownK082891 Lenstar, Model LS900Haag-Streit AG · 2009 · Recalled
- Descendant · 3 generations on · 10 of its ownK101182 Iolmaster 500Carl Zeiss Meditec, AG · 2010 · Recalled
- Descendant · 4 generations on · 9 of its ownK122418 Iolmaster 500Carl Zeiss Meditec, AG · 2013 · Recalled
- Descendant · 3 generations on · 4 of its ownK143275 IOLMaster700Carl Zeiss Meditec, Inc. · 2015
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K030393Optical Low Coherence Reflectometry (Olcr) PachymeterHaag-Streit Holding AG · 2003 · cites it directly16descendants
- K082891Lenstar, Model LS900Haag-Streit AG · 2009 · 2 generations on14descendants
- K101182Iolmaster 500Carl Zeiss Meditec, AG · 2010 · 3 generations on10descendants
- K122418Iolmaster 500Carl Zeiss Meditec, AG · 2013 · 4 generations on9descendants
- K143275IOLMaster700Carl Zeiss Meditec, Inc. · 2015 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955442 | Kowa SC-1200 Photo Slit Lamp System | Kowa Optimed, Inc. | 1996 | — |
| −1 | K991284 | Anterior Eye-Segment Analysis System | Nidek, Inc. | 1999 | — |
| 0 (this device) | K012873 | Documenting Laser Slit Lamp, DP 2010 | Bausch & Lomb, Inc. | 2001 | — |
| +1 | K030393 | Optical Low Coherence Reflectometry (Olcr) Pachymeter | Haag-Streit Holding AG | 2003 | — |
| +2 | K082891 | Lenstar, Model LS900 | Haag-Streit AG | 2009 | 3 |
| +3 | K101182 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2010 | 4 |
| +4 | K122418 | Iolmaster 500 | Carl Zeiss Meditec, AG | 2013 | 4 |
| +3 | K143275 | IOLMaster700 | Carl Zeiss Meditec, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K930518 | Talia Laser SlitSummary page 1…device or legally marketed device or devices to which substantial equivalence is being claimed: Company: Talia Technology, LTD. Device: Talia Laser Slit Lamp 510(k) K930518 Date Cleared: January 25, 1994 Company: Nidek Incorporated Device: Anterior Eye-Segment Analysis System 510(k) K991284 Date C… | 1994 |
| * | K991284 | Anterior Eye-Segment Analysis SystemSummary page 1…gy, LTD. Device: Talia Laser Slit Lamp 510(k) K930518 Date Cleared: January 25, 1994 Company: Nidek Incorporated Device: Anterior Eye-Segment Analysis System 510(k) K991284 Date Cleared: August 6, 1999 4. A description of the device that is the subject of the 510(k), including explanation of how the… | 1999 |
What descends from it? (18)
See all 182 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 5 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K030393 (Haag-Streit Holding AG, 2003) has gone furthest, with 16 descendants of its own.
- 1 other device also cites its predicate K930518.
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 Documenting Laser Slit Lamp is a diagnostic instrument using an AC-powered slit lamp biomicroscope designed to examine the eye through a control diaphragm a thin, intense beam of light.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012873 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012873: Documenting Laser Slit Lamp, DP 2010.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012873
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026