510(k) · Cleared
ClearedKowa SL-15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kowa Co., Ltd. · HJO Biomicroscope, Slit-Lamp, Ac-Powered
Cleared on Dec 18, 2006 as substantially equivalent to K954782 (Kowa Optimed, Inc., 1995) after an 11-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Dec 18, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- HJO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954782 (1995). 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK954782 Kowa Portable Slit Lamp SL-14 & SL-14BKowa Optimed, Inc. · 1995
- This deviceK063640 Kowa SL-15Kowa Co., Ltd. · 2006
- Descendant · cites it directly · 1 of its ownK170470 Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2017
- Descendant · cites it directly · 1 of its ownK133755 Kowa SL-17Kowa Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK222372 Kowa SL-19Kowa Company, Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK193188 MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020
- Descendant · cites it directly · 0 of its ownK100500 PSL Classic Slit LampKeeler Instruments, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K170470Digital Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2017 · cites it directly1descendant
- K133755Kowa SL-17Kowa Co., Ltd. · 2014 · cites it directly1descendant
- K222372Kowa SL-19Kowa Company, Ltd. · 2022 · 2 generations on0descendants
- K193188MiiS Horus Eye Anterior CameraMedimaging Integrated Solution, Inc (Miis) · 2020 · 2 generations on0descendants
- K100500PSL Classic Slit LampKeeler Instruments, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954782 | Kowa Portable Slit Lamp SL-14 & SL-14B | Kowa Optimed, Inc. | 1995 | — |
| 0 (this device) | K063640 | Kowa SL-15 | Kowa Co., Ltd. | 2006 | — |
| +1 | K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017 | — |
| +1 | K133755 | Kowa SL-17 | Kowa Co., Ltd. | 2014 | — |
| +2 | K222372 | Kowa SL-19 | Kowa Company, Ltd. | 2022 | — |
| +2 | K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020 | — |
| +1 | K100500 | PSL Classic Slit Lamp | Keeler Instruments, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 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? (1)
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 |
|---|---|---|---|
| * | K954782 | Kowa Portable Slit Lamp SL-14 & SL-14BSummary page 2…Table A: Predicate device Predicate Device Manufacturer 510(k) No. Date Cleared KOWA Portable Slit Lamp Kowa Company, Ltd. K954782 Nov.24, 1995 SL-14 22 Kow… | 1995 |
What descends from it? (5)
3 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?
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?
KOWA SL-15 is an ophthalmic device indicated for non-invasive illumination, magnification and observation of the human eye. It consists of a hand-held, battery powered slit-lamp biomicroscope with viewing and illumination optical systems and an AC-powered stand.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063640: Kowa SL-15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063640
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