510(k) · Cleared
ClearedMulti Color Laser Photocoagulator, Model MC-300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nidek, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Dec 14, 2004 as substantially equivalent to K032085 (Nidek, Inc., 2003) and 1 other predicate after a 69-day review. Its family tree reaches back 4 generations to 1989. 15 later devices descend from it.
- Decided
- Dec 14, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894841 (1989). 17 ancestors in all, the oldest K812219 (1981). 15 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 3 generations backK960971 Oculight GLIriderm Div. · 1996
- 2 generations backK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- 1 generation backK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- This deviceK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- Descendant · cites it directly · 9 of its ownK110228 Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK152603 Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016
- Descendant · 3 generations on · 3 of its ownK190083 Leaf PhotocoagulatorNorlase Aps · 2019
- Descendant · cites it directly · 2 of its ownK103547 Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011
- Descendant · 4 generations on · 1 of its ownK201623 LION PhotocoagulatorNorlase Aps · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K110228Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · cites it directly9descendants
- K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016 · 2 generations on6descendants
- K190083Leaf PhotocoagulatorNorlase Aps · 2019 · 3 generations on3descendants
- K103547Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011 · cites it directly2descendants
- K201623LION PhotocoagulatorNorlase Aps · 2020 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −3 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −2 | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| −1 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| 0 (this device) | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| +1 | K110228 | Nidek Multicolor Laser Photocoagulator | Nidek Incorporated | 2011 | 4 |
| +2 | K152603 | Green Laser Photocoagulator GYC-500 | Nidek Co., Ltd. | 2016 | — |
| +3 | K190083 | Leaf Photocoagulator | Norlase Aps | 2019 | — |
| +1 | K103547 | Lightlas Multi-Wavelength Medical Laser System | Lightmed Corp. | 2011 | — |
| +4 | K201623 | LION Photocoagulator | Norlase Aps | 2020 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K032085 | Green Laser Photocoagulator Model Gyc-1000Summary page 2…% r IM Predicate Device Manufacturer 510(k) No. Date Cleared Nidek Laser Photocoagulator Nidek Co. Ltd. K032085 October 3, Model GYC-1000 Japan 2003 Lumenis N… | 2003 |
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 2…October 3, Model GYC-1000 Japan 2003 Lumenis Novus Varia Lumenis, Inc. K022181 October 1, Ophthalmic Laser & 2002 Delivery… | 2002 |
What descends from it? (15)
See all 153 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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K110228 (Nidek Incorporated, 2011) has gone furthest, with 9 descendants of its own.
- 3 other devices also cite its predicate K032085.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Nidek Multi Color Laser Photocoagulator Model MC-300 is indicated 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/K042785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042785: Multi Color Laser Photocoagulator, Model MC-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042785
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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