510(k) · Cleared
ClearedCeemax Slit Lamp (Halogen Lamp Series/Solid State Illumination Series)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acheve Technology, Inc. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Jun 24, 2008 as substantially equivalent to K061330 (Reichert, Inc., 2006) and 1 other predicate after a 263-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Jun 24, 2008
- Review
- 263 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033190 (2003). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK033190 Vision-Tech YZ Slit Lamp, Model 66Suzhou 66 Vision-Tech Co., Ltd. · 2003
- This deviceK072861 Ceemax Slit Lamp (Halogen Lamp Series/Solid State Illumination Series)Acheve Technology, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033190 | Vision-Tech YZ Slit Lamp, Model 66 | Suzhou 66 Vision-Tech Co., Ltd. | 2003 | — |
| 0 (this device) | K072861 | Ceemax Slit Lamp (Halogen Lamp Series/Solid State Illumination Series) | Acheve Technology, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | K061330 | PSL Portable Slit LampSummary page 1…egulation Number: 886.1850 Product Code: HJO Class: II 3. PREDICATE DEVICES (1) Reichert PSL Slit Lamp ---- FDA 510K K061330 (2) VISION-TECH YZ SLIT LAMP ---- FDA 510K K033190 4. DEVICE DESCRIPTION The CeeMax TM Slit Lamp's (Halogen Lam… | 2006 |
| * | K033190 | Vision-Tech YZ Slit Lamp, Model 66Summary page 1…HJO Class: II 3. PREDICATE DEVICES (1) Reichert PSL Slit Lamp ---- FDA 510K K061330 (2) VISION-TECH YZ SLIT LAMP ---- FDA 510K K033190 4. DEVICE DESCRIPTION The CeeMax TM Slit Lamp's (Halogen Lamp Series/LED Illumination series) with models of 80… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K061330.
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. 2008, 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 CeeMaxTM slit-lamp series is an AC-powered slit-lamp biomicroscope
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 summary.
https://510kreport.com/device/K072861 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072861: Ceemax Slit Lamp (Halogen Lamp Series/Solid State Illumination Series).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072861
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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