510(k) · Cleared
ClearedSlit Lamp SL-2G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Topcon Medical Systems, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on May 23, 2011 as substantially equivalent to K100202 (Haag-Streit AG, 2010) and 1 other predicate after a 90-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it.
- Decided
- May 23, 2011
- Review
- 90 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K982057 (1998). 5 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK982057 BC 900 Slit LampHaag-Streit AG · 1998
- 1 generation backK100202 Slit Lamp BO 900, BQ 900, BP900Haag-Streit AG · 2010
- This deviceK110489 Slit Lamp SL-2GTopcon Medical Systems, Inc. · 2011
- Descendant · cites it directly · 2 of its ownK133667 Slit Lamp SL-D701Topcon Corp. · 2014
- Descendant · cites it directly · 1 of its ownK152535 Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK262637 SLIT LAMP SL-D4 (Type: LED)Topcon Corporation · 2026
- Descendant · 2 generations on · 0 of its ownK162636 Marco Ultra M3, Marco Ultra M4Takagi Seiko Co., Ltd. · 2017
- Descendant · 2 generations on · 0 of its ownK161972 Slit Lamp SL-D301Topcon Corporation · 2016
Most influential descendants
Showing 5 of 5 · See all- K133667Slit Lamp SL-D701Topcon Corp. · 2014 · cites it directly2descendants
- K152535Z5 Slit lamp microscope, Z2 Slit lamp microscopeTakagi Seiko Co., Ltd. · 2016 · cites it directly1descendant
- K262637SLIT LAMP SL-D4 (Type: LED)Topcon Corporation · 2026 · 2 generations on0descendants
- K162636Marco Ultra M3, Marco Ultra M4Takagi Seiko Co., Ltd. · 2017 · 2 generations on0descendants
- K161972Slit Lamp SL-D301Topcon Corporation · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982057 | BC 900 Slit Lamp | Haag-Streit AG | 1998 | — |
| −1 | K100202 | Slit Lamp BO 900, BQ 900, BP900 | Haag-Streit AG | 2010 | — |
| 0 (this device) | K110489 | Slit Lamp SL-2G | Topcon Medical Systems, Inc. | 2011 | — |
| +1 | K133667 | Slit Lamp SL-D701 | Topcon Corp. | 2014 | — |
| +1 | K152535 | Z5 Slit lamp microscope, Z2 Slit lamp microscope | Takagi Seiko Co., Ltd. | 2016 | — |
| +2 | K262637 | SLIT LAMP SL-D4 (Type: LED) | Topcon Corporation | 2026 | — |
| +2 | K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | 2017 | — |
| +2 | K161972 | Slit Lamp SL-D301 | Topcon Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K100202 | Slit Lamp BO 900, BQ 900, BP900Summary page 2…ssification Name AC-powered slitlamp biomicroscope; 21 C.F R. 886.1850 Class 11 Product Code: HJO Predicate Devices Haag-Streit AG BM 900IBQ 900/ BP 900 (K100202) Haag-Streit AG BC 900 (K(982057) Device Description The Slit Lamp SL-2G is an AC-powered device that is a microscope intended f… | 2010 |
| * | K982057 | BC 900 Slit LampSummary page 2…ntial Equivalence The Topcon Slit Lamp SL-2G is substantially equivalent to the predicate devices, the HAAG-STREIT Slit Lamps BM 900/BQ 900/1BP 900 (K100202) and BC 900 (K982057). The Slit Lamp SL-2G and the predicated devices have the same intended use and indications for use as the predicate devices. Th… | 1998 |
What descends from it? (5)
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 13 years and passes through 2 companies; a new generation was cleared every 11.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133667 (Topcon Corp., 2014) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K100202.
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. 2011, 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 SlitLamp SL-2G is an AC-powered slitlamp biomicroscope intended for
use in eye examination of the anterior eye segment, from the cornea
epithelium to the posterior capsule. It is used to aid in the diagnosis of
diseases or trauma which affect the structural properties of the anterior eye
segment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110489 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110489: Slit Lamp SL-2G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110489
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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