510(k) · Cleared
ClearedEVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dutch Ophthalmic Research Center International BV · HQC Unit, Phacofragmentation
Cleared on Mar 13, 2015 as substantially equivalent to K081877 (Dutch Ophthalmic Research Center International BV, 2009) and 5 other predicates after a 163-day review. Its family tree reaches back 7 generations to 1994. 5 later devices descend from it.
- Decided
- Mar 13, 2015
- Review
- 163 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 7 generations to K933880 (1994). 53 ancestors in all, the oldest K844373 (1985). 5 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 6 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 5 generations backK964074 Diolite 532Iriderm Div. · 1997
- 4 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 3 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 2 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 1 generation backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- This deviceK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- Descendant · cites it directly · 2 of its ownK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- Descendant · cites it directly · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK212241 Quatera 700Carl Zeiss Meditec, AG · 2022
- Descendant · 2 generations on · 0 of its ownK250501 System SophiThis AG · 2025
- Descendant · 2 generations on · 0 of its ownK230858 Quatera 700Carl Zeiss Meditec, AG · 2023
Most influential descendants
Showing 5 of 5 · See all- K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · cites it directly2descendants
- K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · cites it directly1descendant
- K212241Quatera 700Carl Zeiss Meditec, AG · 2022 · cites it directly1descendant
- K250501System SophiThis AG · 2025 · 2 generations on0descendants
- K230858Quatera 700Carl Zeiss Meditec, AG · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −6 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −5 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −4 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −3 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −2 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −1 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| 0 (this device) | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| +1 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | 1 |
| +1 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
| +1 | K212241 | Quatera 700 | Carl Zeiss Meditec, AG | 2022 | — |
| +2 | K250501 | System Sophi | This AG | 2025 | — |
| +2 | K230858 | Quatera 700 | Carl Zeiss Meditec, AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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 HQC? 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 HQC device
- #1 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | K081877 | Associate 2500 Dual and Compact SystemsSummary page 4…70 Phacofragmentation System e 21 CFR 886.4150 Vitreous Aspirating and Cutting Device e 21 CFR 886.4390 Ophthalmic Laser 5.3. Predicate Devices 510(k) Number Device KO081877 Associate 2500 dual and compact systems (DORC) K101285 Constellation Vision System (Alcon) K101325 Stellaris PC Vision Enhanceme… | 2009 |
| * | K101285 | Constellation Vision SystemSummary page 4…us Aspirating and Cutting Device e 21 CFR 886.4390 Ophthalmic Laser 5.3. Predicate Devices 510(k) Number Device KO081877 Associate 2500 dual and compact systems (DORC) K101285 Constellation Vision System (Alcon) K101325 Stellaris PC Vision Enhancement System (Bausch & Lomb) K102222 Ultimate Vit Enhancer… | 2010 |
| * | K101325 | Stellaris PC Vision Enhancement SystemSummary page 4….4390 Ophthalmic Laser 5.3. Predicate Devices 510(k) Number Device KO081877 Associate 2500 dual and compact systems (DORC) K101285 Constellation Vision System (Alcon) K101325 Stellaris PC Vision Enhancement System (Bausch & Lomb) K102222 Ultimate Vit Enhancer (MID Labs) K121675 VersaVit (Synergetics)… | 2010 |
| * | K102222 | Ultimate Vit Enhamcer (Uve)Summary page 4…vice KO081877 Associate 2500 dual and compact systems (DORC) K101285 Constellation Vision System (Alcon) K101325 Stellaris PC Vision Enhancement System (Bausch & Lomb) K102222 Ultimate Vit Enhancer (MID Labs) K121675 VersaVit (Synergetics) K062624 Next Generation Laser (PurePoint; Alcon) Page 1 of 7… | 2011 |
| * | K121675 | VersavitSummary page 4…pact systems (DORC) K101285 Constellation Vision System (Alcon) K101325 Stellaris PC Vision Enhancement System (Bausch & Lomb) K102222 Ultimate Vit Enhancer (MID Labs) K121675 VersaVit (Synergetics) K062624 Next Generation Laser (PurePoint; Alcon) Page 1 of 7 DORC Traditional 510(k) EV… | 2012 |
| * | K062624 | Next Generation LaserSummary page 4…tellation Vision System (Alcon) K101325 Stellaris PC Vision Enhancement System (Bausch & Lomb) K102222 Ultimate Vit Enhancer (MID Labs) K121675 VersaVit (Synergetics) K062624 Next Generation Laser (PurePoint; Alcon) Page 1 of 7 DORC Traditional 510(k) EVA System 5.4. Device Descriptio… | 2007 |
What descends from it? (5)
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)
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 21 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 16 of the 53 ancestors have a recall of any class.
- Of its descendants, K190875 (D.O.R.C. Dutch Ophthalmic Research Center (International), 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K081877.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, 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 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal) ophthalmic surgery. In addition, the optional laser is indicated for the following: Condition Treatment Diabetic Retinopathy x Proliferative Diabetic Retinopathy Panretinal Photocoagulation x Clinically Significant Macular Edema Focal or Grid Laser Retinal Tear and Detachments Laser…
Read the full statement (111 words)
The EVA Ophthalmic Surgical System is indicated for both anterior segment (i.e.
phacoemulsification and removal of cataracts) and posterior segment (i.e., vitreoretinal)
ophthalmic surgery.
In addition, the optional laser is indicated for the following:
Condition Treatment
Diabetic Retinopathy
x Proliferative Diabetic Retinopathy Panretinal Photocoagulation
x Clinically Significant Macular Edema Focal or Grid Laser
Retinal Tear and Detachments Laser Retinopathy
Lattice Degeneration Retinal Photocoagulation
Sub-retinal (choroidal) Neovascularization Focal Laser
Retinal Vascular Occlusion
x Neovascularization secondary to Brand or Central retinal Scatter Laser
vein occlusion Photocoagulation
x Chronic macular edema secondary to Branch or Central Focal or Grid Laser
retinal vein occlusion
Glaucoma
x Primary Open-angle Trabeculoplasty
x Closed Angle Iridotomy or Iridoplasty
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/K142877 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142877: EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser SMA connector).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142877
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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