510(k) · Cleared
ClearedPSL Portable Slit Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reichert, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on May 25, 2006 after a 13-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- May 25, 2006
- Review
- 13 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK061330 PSL Portable Slit LampReichert, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK153545 Portable Slit LampShanghai Bolan Optical-Electric Co., Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK072861 Ceemax Slit Lamp (Halogen Lamp Series/Solid State Illumination Series)Acheve Technology, Inc. · 2008
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061330 | PSL Portable Slit Lamp | Reichert, Inc. | 2006 | — |
| +1 | K153545 | Portable Slit Lamp | Shanghai Bolan Optical-Electric Co., Ltd. | 2016 | — |
| +1 | K072861 | Ceemax Slit Lamp (Halogen Lamp Series/Solid State Illumination Series) | Acheve Technology, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (2)
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?
- Of its descendants, K153545 (Shanghai Bolan Optical-Electric Co., Ltd., 2016) has gone furthest, with 0 descendants of its own.
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?
A slitlamp biomicroscope is intended for use in eye examination of the anterior 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 510(k) statement.
https://510kreport.com/device/K061330 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061330: PSL Portable Slit Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061330
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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