510(k) · Cleared
Recalled · Class II · 2014Nidek Multicolor Laser Photocoagulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Incorporated · HQB Photocoagulator And Accessories
Cleared on Feb 23, 2011 as substantially equivalent to K042785 (Nidek, Inc., 2004) after a 28-day review. Its family tree reaches back 5 generations to 1989. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Feb 23, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- HQB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 5 generations to K894841 (1989). 18 ancestors in all, the oldest K812219 (1981). 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 4 generations backK960971 Oculight GLIriderm Div. · 1996
- 3 generations backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 2 generations backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- 1 generation backK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- This deviceK110228 Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 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 · 2 generations on · 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 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · 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 · 2 generations on1descendant
- 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 |
|---|---|---|---|---|---|
| −5 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −4 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −3 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −2 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| −1 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| 0 (this device) | K110228 | Nidek Multicolor Laser Photocoagulator | Nidek Incorporated | 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 | — |
| +2 | K170302 | Yellow Laser Photocoagulator Ylc-500 | Nidek Co., Ltd. | 2017 | — |
| +4 | K251507 | Integre Lio | Quantel Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 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), 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 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? (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 |
|---|---|---|---|
| * | K042785 | Multi Color Laser Photocoagulator, Model MC-300Summary page 1…icolor Laser Photocoagulator System MC-500 Generic/Common Name: Ophthalmic Laser Photocoagulator Predicate Device Nidek Multi Color Laser Photocoagulator Model MC-300 (K042785) Intended Use The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures,… | 2004 |
What descends from it? (9)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 9, 2014 | Class II | Z-2132-2014 | Error in labeling | Laser aperture label was not affixed to device prior to shipment in the US. |
| May 24, 2013 | Class II | Z-0222-2015 | Software design | Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. |
| Oct 24, 2012 | Class II | Z-0224-2015 | Device Design | When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the power output is lower than the set program. |
| Mar 27, 2012 | Class II | Z-1127-2015 | Component design/selection | The spot size control of the scan delivery unit of the MC-500 Multicolor Laser Photocoagulator may turn by itself. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K152603 (Nidek Co., Ltd., 2016) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K042785.
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 | — |
What is it indicated for?
The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110228: Nidek Multicolor Laser Photocoagulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110228
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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