510(k) · Cleared
ClearedXcel 255 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 Dec 20, 2006 after a 1-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Dec 20, 2006
- Review
- 1 day
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK063750 Xcel 255 Slit LampReichert, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK082031 Appasamy Slit Lamp, A1A-11 and A1A-12 SeriesAppasamy Associates · 2008
- Descendant · 2 generations on · 5 of its ownK110129 Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011
- Descendant · 3 generations on · 4 of its ownK133476 Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG · 2014
- Descendant · 4 generations on · 1 of its ownK162684 SL 220Carl Zeiss Meditec, AG · 2017
- Descendant · 5 generations on · 0 of its ownK253834 Visuref 600Carl Zeiss Vision GmbH · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K082031Appasamy Slit Lamp, A1A-11 and A1A-12 SeriesAppasamy Associates · 2008 · cites it directly7descendants
- K110129Righton Zoom Slit Lamp Microscope with Photo OptionRightmedical Products, LLC · 2011 · 2 generations on5descendants
- K133476Slit Lamps with SL Cam 5.0 Digital Imaging SolutionCarl Zeiss Meditec, AG · 2014 · 3 generations on4descendants
- K162684SL 220Carl Zeiss Meditec, AG · 2017 · 4 generations on1descendant
- K253834Visuref 600Carl Zeiss Vision GmbH · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063750 | Xcel 255 Slit Lamp | Reichert, Inc. | 2006 | — |
| +1 | K082031 | Appasamy Slit Lamp, A1A-11 and A1A-12 Series | Appasamy Associates | 2008 | — |
| +2 | K110129 | Righton Zoom Slit Lamp Microscope with Photo Option | Rightmedical Products, LLC | 2011 | — |
| +3 | K133476 | Slit Lamps with SL Cam 5.0 Digital Imaging Solution | Carl Zeiss Meditec, AG | 2014 | — |
| +4 | K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017 | — |
| +5 | K253834 | Visuref 600 | Carl Zeiss Vision GmbH | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 4 | 0 |
| 2026 | 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? (9)
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, K082031 (Appasamy Associates, 2008) has gone furthest, with 7 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?
An AC-Powered 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/K063750 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063750: Xcel 255 Slit Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063750
Report an extraction error
Are you the manufacturer?
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