510(k) · Cleared
ClearedNidek Prima Model Gyc-1500/2000
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 May 13, 1998 as substantially equivalent to K962592 (Alcon Laboratories, 1996) and 3 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1989. 18 later devices descend from it.
- Decided
- May 13, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K894841 (1989). 7 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 1 generation backK960971 Oculight GLIriderm Div. · 1996
- This deviceK980547 Nidek Prima Model Gyc-1500/2000Nidek, Inc. · 1998
- Descendant · cites it directly · 17 of its ownK032085 Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 15 of its ownK042785 Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004
- Descendant · 3 generations on · 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
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K032085Green Laser Photocoagulator Model Gyc-1000Nidek, Inc. · 2003 · cites it directly17descendants
- K042785Multi Color Laser Photocoagulator, Model MC-300Nidek, Inc. · 2004 · 2 generations on15descendants
- K110228Nidek Multicolor Laser PhotocoagulatorNidek Incorporated · 2011 · 3 generations on9descendants
- K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd. · 2016 · 2 generations on6descendants
- K190083Leaf PhotocoagulatorNorlase Aps · 2019 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −1 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| 0 (this device) | K980547 | Nidek Prima Model Gyc-1500/2000 | Nidek, Inc. | 1998 | — |
| +1 | K032085 | Green Laser Photocoagulator Model Gyc-1000 | Nidek, Inc. | 2003 | 3 |
| +2 | K042785 | Multi Color Laser Photocoagulator, Model MC-300 | Nidek, Inc. | 2004 | — |
| +3 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2013 | 2 | 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? (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 |
|---|---|---|---|
| * | K962592 | Ophthalas 532 Solid State Photocoagulator, or Equivalent Laser SystemsSummary page 1…226-5750 2. Device Name: Models GYC-1500 and GYC-2000 Solid state ophthalmic laser photocoagulator Ophthalmic Laser 3. Predicate Devices: Model Ophthalas 532 by Alcon (K962592) Model Cerlas G by CeramOptec (K962948) Model Oculight GL by Iris (K960971) Models GYC-1500/2000 (K951079) - The purpose of this… | 1996 |
| * | K962948 | Ceralas G ND;Yag Laser System (Ceralas G)Summary page 1…00 and GYC-2000 Solid state ophthalmic laser photocoagulator Ophthalmic Laser 3. Predicate Devices: Model Ophthalas 532 by Alcon (K962592) Model Cerlas G by CeramOptec (K962948) Model Oculight GL by Iris (K960971) Models GYC-1500/2000 (K951079) - The purpose of this application is to add two indications o… | 1996 |
| * | K960971 | Oculight GLSummary page 1…ic laser photocoagulator Ophthalmic Laser 3. Predicate Devices: Model Ophthalas 532 by Alcon (K962592) Model Cerlas G by CeramOptec (K962948) Model Oculight GL by Iris (K960971) Models GYC-1500/2000 (K951079) - The purpose of this application is to add two indications of iridotomy and trabeculoplasty, to… | 1996 |
| * | K951079 | Nidek Model Gyc-1500 and Gyc-2000Summary page 1…lmic Laser 3. Predicate Devices: Model Ophthalas 532 by Alcon (K962592) Model Cerlas G by CeramOptec (K962948) Model Oculight GL by Iris (K960971) Models GYC-1500/2000 (K951079) - The purpose of this application is to add two indications of iridotomy and trabeculoplasty, to the current 510(k). GYC-1500 ha… | 1995 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032085 | Green Laser Photocoagulator Model Gyc-1000 | 2003 | 17 |
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 9 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K032085 (Nidek, Inc., 2003) has gone furthest, with 17 descendants of its own.
- 3 other devices also cite its predicate K962592.
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 Prima Frequency doubled Nd:YAG Laser is intended to be used in all clinical applications for which an Argon Laser would be used in ophthalmic surgery, including Retinal and Macular Photocoagulation; Tridotomy and Trabeculoplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980547: Nidek Prima Model Gyc-1500/2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980547
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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