510(k) · Cleared
ClearedOphthalmic Yag Laser System YC-200
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 Dec 7, 2020 as substantially equivalent to K192045 (Nidek Co., Ltd., 2019) and 1 other predicate after a 49-day review. Its family tree reaches back 7 generations to 1989.
- Decided
- Dec 7, 2020
- Review
- 49 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K894841 (1989). 18 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 7 generations backK894841 Iris Oculight (TM) SLIriderm Div. · 1989
- 6 generations backK960971 Oculight GLIriderm Div. · 1996
- 5 generations backK022181 Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesLumenis, Inc. · 2002
- 4 generations backK081704 Selecta Family of Ophithalmic Laser SystemsLumenis, Inc. · 2008
- 3 generations backK130933 SolutisQuantel Medical · 2013
- 2 generations backK140336 Optimus Fusion: SLT, Yag and Yag/SLTQuantel Medical · 2014
- 1 generation backK192045 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2019
- This deviceK203130 Ophthalmic Yag Laser System YC-200Nidek Co., Ltd. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K894841 | Iris Oculight (TM) SL | Iriderm Div. | 1989 | — |
| −6 | K960971 | Oculight GL | Iriderm Div. | 1996 | — |
| −5 | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with Accessories | Lumenis, Inc. | 2002 | — |
| −4 | K081704 | Selecta Family of Ophithalmic Laser Systems | Lumenis, Inc. | 2008 | — |
| −3 | K130933 | Solutis | Quantel Medical | 2013 | — |
| −2 | K140336 | Optimus Fusion: SLT, Yag and Yag/SLT | Quantel Medical | 2014 | — |
| −1 | K192045 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 2019 | — |
| 0 (this device) | K203130 | Ophthalmic Yag Laser System YC-200 | Nidek Co., Ltd. | 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 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 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? (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 |
|---|---|---|---|
| * | K192045 | Ophthalmic Yag Laser System YC-200Summary page 6…Product Code: HQF, HJO PREDICATE AND REFERENCE DEVICES • NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200 (as the primary predicate de- vice)( K192045) • Ellex Medical Pty. Ltd. LUMENIS SELECTA DUET (as a predicate device)(K021550) • NIDEK Green Laser Photocoagulator GYC-50… | 2019 |
| * | K021550 | Lumenis Selecta DuetSummary page 6…• NIDEK OPHTHALMIC YAG LASER SYSTEM YC-200 (as the primary predicate de- vice)( K192045) • Ellex Medical Pty. Ltd. LUMENIS SELECTA DUET (as a predicate device)(K021550) • NIDEK Green Laser Photocoagulator GYC-500 (as a reference device)(K152603) INDICATIONS FOR USE The OPHTHALMIC YAG LASER S… | 2002 |
| † | K152603 | Green Laser Photocoagulator GYC-500 | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 18 ancestors has a recall.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 OPHTHALMIC YAG LASER SYSTEM YC-200 consists of a slit lamp and the YAG Laser and is indicated for the performance of posterior capsulotomy, posterior membranectomy, pupillary membranectomy, iridotomy (hole in the iris) and selective laser trabeculoplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203130 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203130: Ophthalmic Yag Laser System YC-200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203130
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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