510(k) · Cleared
ClearedNidek Multicolor Scan Laser Photocoagulator MC-500 Vixi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Co., Ltd. · HQB Photocoagulator And Accessories
Cleared on Jul 27, 2011 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Jul 27, 2011
- Review
- 57 days
- Class
- Class II
- Product code
- HQB
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 3 citing it directly.
- This deviceK111493 Nidek Multicolor Scan Laser Photocoagulator MC-500 VixiNidek Co., Ltd. · 2011
- Descendant · cites it directly · 6 of its ownK152603 Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016
- Descendant · 2 generations on · 3 of its ownK190083 Leaf PhotocoagulatorNorlase Aps · 2019
- Descendant · 3 generations on · 1 of its ownK201623 LION PhotocoagulatorNorlase Aps · 2020
- Descendant · cites it directly · 1 of its ownK170302 Yellow Laser Photocoagulator Ylc-500Nidek Co., Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK251507 Integre LioQuantel Medical · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016 · cites it directly6descendants
- K190083Leaf PhotocoagulatorNorlase Aps · 2019 · 2 generations on3descendants
- K201623LION PhotocoagulatorNorlase Aps · 2020 · 3 generations on1descendant
- K170302Yellow Laser Photocoagulator Ylc-500Nidek Co., Ltd. · 2017 · cites it directly1descendant
- K251507Integre LioQuantel Medical · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K111493 | Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi | Nidek Co., Ltd. | 2011 | — |
| +1 | K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016 | — |
| +2 | K190083 | Leaf Photocoagulator | Norlase Aps | 2019 | — |
| +3 | K201623 | LION Photocoagulator | Norlase Aps | 2020 | — |
| +1 | K170302 | Yellow Laser Photocoagulator Ylc-500 | Nidek Co., Ltd. | 2017 | — |
| +4 | K251507 | Integre Lio | Quantel Medical | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQB? 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 HQB device
- #1 K220263 Vortex Surgical Laser Probes, Vortex Surgical…score 3.8 · 6 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
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?
- Of its descendants, K152603 (Nidek Co., Ltd., 2016) has gone furthest, with 6 descendants of its own.
How does its category compare?
All HQB devicesHQB Photocoagulator And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HQB
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · HQB
221in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQB
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQB
7in 2025
MAUDE reports naming product code HQB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 57 | 0 | 3 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 3 | 221 | 28 | 2 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 2 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 14 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 2 | 7 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K111493 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111493: Nidek Multicolor Scan Laser Photocoagulator MC-500 Vixi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111493
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026