510(k) · Cleared
ClearedPiccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirchner & Wilhelm GmbH + Co.Kg · HLJ Ophthalmoscope, Battery-Powered
Cleared on Nov 5, 2007 as substantially equivalent to K925756 (Rudolf Riester GmbH & Co. KG, 1993) and 2 other predicates after a 280-day review. Its family tree reaches back 1 generation to 1993. 4 later devices descend from it.
- Decided
- Nov 5, 2007
- Review
- 280 days
- Class
- Class II
- Product code
- HLJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K925757 (1993). 3 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK925757 OphthalmoscopeRudolf Riester GmbH & Co. KG · 1993
- This deviceK070270 Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and…Kirchner & Wilhelm GmbH + Co.Kg · 2007
- Descendant · cites it directly · 3 of its ownK123587 Heine Mini 3000 Led OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013
- Descendant · 2 generations on · 0 of its ownK142486 Heine Beta 200, Heine Beta 200 S, Heine K 180Heine Optotechnik GmbH & Co. KG · 2015
- Descendant · 2 generations on · 0 of its ownK131959 Heine Mini 3000(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2014
- Descendant · 2 generations on · 0 of its ownK131961 Heine Beta 200(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013
Most influential descendants
Showing 4 of 4 · See all- K123587Heine Mini 3000 Led OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013 · cites it directly3descendants
- K142486Heine Beta 200, Heine Beta 200 S, Heine K 180Heine Optotechnik GmbH & Co. KG · 2015 · 2 generations on0descendants
- K131959Heine Mini 3000(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2014 · 2 generations on0descendants
- K131961Heine Beta 200(R) OphthalmoscopeHeine Optotechnik GmbH & Co. KG · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925757 | Ophthalmoscope | Rudolf Riester GmbH & Co. KG | 1993 | — |
| 0 (this device) | K070270 | Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36 | Kirchner & Wilhelm GmbH + Co.Kg | 2007 | — |
| +1 | K123587 | Heine Mini 3000 Led Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2013 | — |
| +2 | K142486 | Heine Beta 200, Heine Beta 200 S, Heine K 180 | Heine Optotechnik GmbH & Co. KG | 2015 | — |
| +2 | K131959 | Heine Mini 3000(R) Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2014 | — |
| +2 | K131961 | Heine Beta 200(R) Ophthalmoscope | Heine Optotechnik GmbH & Co. KG | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 HLJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K925756 | UNI IISummary page 1…ode and HLJ CFR Regulation Number: 21 CFR 886.1570 Classification Panel: Ophthalmic Uni II (K925756) RI-MINI (K932503) Ophthalmoscope (K932503) Predica… | 1993 |
| * | K932503 | RI-MiniSummary page 1…21 CFR 886.1570 Classification Panel: Ophthalmic Uni II (K925756) RI-MINI (K932503) Ophthalmoscope (K932503) Predicate Device Names and 510(k) Heine Beta 200S (Device L… | 1993 |
| * | K925757 | OphthalmoscopeSummary page 2…CHNER &WILHEaM Piccolight® E50 Riester ophthalmoscopes PeWdzO .C Scope® (K925757) Intended use An ophthalmoscope is intended to Same be used to examine the cornea, aqueo… | 1993 |
| * | — | HEINE BETA 200 S ophthalmoscope Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123587 | Heine Mini 3000 Led Ophthalmoscope | 2013 | 3 |
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 HLJ devicesHLJ Ophthalmoscope, Battery-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · HLJ
2in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · HLJ
140in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HLJ
No recall names HLJ since 2007.
Adverse event reports per year · HLJ
1in 2023
MAUDE reports naming product code HLJ, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 3 | 140 | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
An ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous and retina of the eye.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070270: Piccolight E50,Piccolight E56,Eurolight E10, Eurolight E30, and Eurolight E36.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070270
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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