510(k) · Cleared
Recalled · Class II · 2019EVA, 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
D.O.R.C. Dutch Ophthalmic Research Center (International) · HQC Unit, Phacofragmentation
Cleared on Sep 25, 2019 as substantially equivalent to K142877 (Dutch Ophthalmic Research Center International BV, 2015) and 2 other predicates after a 174-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it. It has been recalled once.
- Decided
- Sep 25, 2019
- Review
- 174 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K933880 (1994). 57 ancestors in all, the oldest K844373 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 7 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 6 generations backK964074 Diolite 532Iriderm Div. · 1997
- 5 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 4 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 3 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 2 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 1 generation backK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- This deviceK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019
- Descendant · cites it directly · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK250501 System SophiThis AG · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −7 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −6 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −5 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −4 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −3 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −2 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −1 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| 0 (this device) | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | — |
| +1 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
| +2 | K250501 | System Sophi | This AG | 2025 | — |
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 | 6 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…Summary page 5…configurations added. No new accessories that were not previously cleared were added. 5.3. Predicate Device(s) 510(k) Number Device Primary Predicate: K142877 EVA Ophthalmic Surgical System (DORC) Additional Predicates: K101285 Constellation Vision System (Alcon)… | 2015 |
| * | K101285 | Constellation Vision SystemSummary page 5…were added. 5.3. Predicate Device(s) 510(k) Number Device Primary Predicate: K142877 EVA Ophthalmic Surgical System (DORC) Additional Predicates: K101285 Constellation Vision System (Alcon) K133486 Stellaris PC Vision Enhancement System (Bausch & Lomb)… | 2010 |
| * | K133486 | Stellaris PC Vision Enhancement SystemSummary page 5…Device Primary Predicate: K142877 EVA Ophthalmic Surgical System (DORC) Additional Predicates: K101285 Constellation Vision System (Alcon) K133486 Stellaris PC Vision Enhancement System (Bausch & Lomb) Page 2 of 5 K19087… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213467 | EVA NEXUS Ophthalmic Surgical System | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 21, 2019 | Class II | Z-2252-2021 | Under Investigation by firm | Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC 25g, containing 23-gauge infusion line |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 4.2 years on median.
- 17 of the 57 ancestors have a recall of any class.
- Of its descendants, K213467 (D.O.R.C. Dutch Ophthalmic Research Center (International), 2022) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K142877.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 * Proliferative Diabetic Retinopathy..........................Panretinal Photocoagulation * Clinically Significant Macular Edema....................Focal or Grid…
Read the full statement (102 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
* Proliferative Diabetic Retinopathy..........................Panretinal Photocoagulation
* Clinically Significant Macular Edema....................Focal or Grid Laser
Retinal Tear and Detachments....................................Laser Retinopathy
Lattics Degeneration...................................................Retinal Photocoagulation
Sub-retinal (choroidal) Neovascularization................Focal laser
Retinal Vascular Occlusion
* Neovascularization secondary to Branch
or Central retinal vein occlusion...............................Scatter Laser Photocoagulation
* Chronic macular edema secondary to Branch
or Central retinal vein occlusion...............................Focal or Grid Laser
Glaucoma
* Primary Open-angle..................................................Trabeculoplasty
* Closed Angle.............................................................Iridotomy or Iridoplasty
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190875: 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/K190875
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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