510(k) · Cleared
Recalled · Class II · 2015Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the Endophotocoagulation Delivery Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek Co., Ltd. · HQF Laser, Ophthalmic
Cleared on Aug 12, 2014 as substantially equivalent to K110228 (Nidek Incorporated, 2011) and 3 other predicates after a 285-day review. Its family tree reaches back 6 generations to 1989. It has been recalled 2 times.
- Decided
- Aug 12, 2014
- Review
- 285 days
- Class
- Class II
- Product code
- HQF
- Recalls
- 2
- Predicates
- 4
Its longest line of descent runs back 6 generations to K894841 (1989). 27 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 6 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 5 generations backK960971 Oculight GLIriderm Div. · 1996
- 4 generations backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 3 generations backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- 2 generations backK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- 1 generation backK110228 Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · Recalled
- This deviceK133358 Nidek Multicolor Laser Photocoagulator System MC-500 Connected with…Nidek Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −5 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −4 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −3 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| −2 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| −1 | K110228 | Nidek Multicolor Laser Photocoagulator | Nidek Incorporated | 2011 | 4 |
| 0 (this device) | K133358 | Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the… | Nidek Co., Ltd. | 2014 | — |
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 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2013 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K110228 | Nidek Multicolor Laser PhotocoagulatorSummary page 5…ophoto probe) Generic/Common Name: Endophotocoagulation Delivery Unit (for sterilized endophoto probe) Predicate Device Multicolor Laser Photocoagulator System MC‐500 (K110228) OphthalMed 20G and 25G SMA Laser Fibers (K021696) Peregrine 23ga Curved Illuminating Laser Probe (K122997) Green Laser Photocoag… | 2011 |
| * | K021696 | 20G Sma Laser Fiber, Model LF20; 25G Sma Laser Fiber, Model LF25Summary page 5…lation Delivery Unit (for sterilized endophoto probe) Predicate Device Multicolor Laser Photocoagulator System MC‐500 (K110228) OphthalMed 20G and 25G SMA Laser Fibers (K021696) Peregrine 23ga Curved Illuminating Laser Probe (K122997) Green Laser Photocoagulator GYC-1000 (K032085) Indications for use The… | 2002 |
| * | K122997 | 23GA Curved Illuminating Laser ProbeSummary page 5…edicate Device Multicolor Laser Photocoagulator System MC‐500 (K110228) OphthalMed 20G and 25G SMA Laser Fibers (K021696) Peregrine 23ga Curved Illuminating Laser Probe (K122997) Green Laser Photocoagulator GYC-1000 (K032085) Indications for use The Endophotocoagulation Delivery Unit (for sterilized endop… | 2013 |
| * | K032085 | Green Laser Photocoagulator Model Gyc-1000Summary page 5…System MC‐500 (K110228) OphthalMed 20G and 25G SMA Laser Fibers (K021696) Peregrine 23ga Curved Illuminating Laser Probe (K122997) Green Laser Photocoagulator GYC-1000 (K032085) Indications for use The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is intended to be used in ophthalmi… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 25, 2015 | Class II | Z-2068-2015 | Error in labeling | Accessories to the GYC-1000 laser were missing Laser Aperture labels. |
| Mar 25, 2015 | Class II | Z-2067-2015 | Error in labeling | Accessories to the GYC-1000 laser were missing Laser Aperture labels. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 4 of the 27 ancestors have a recall of any class.
- 2 other devices also cite its predicate K110228.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Endophotocoagulation Delivery Unit (for sterilized endophoto probe) is intended to be used in ophthalmic surgical procedures for retinal photocoagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133358 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133358: Nidek Multicolor Laser Photocoagulator System MC-500 Connected with the Endophotocoagulation Delivery Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133358
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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