510(k) · Cleared
ClearedSystem Sophi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
This AG · HQC Unit, Phacofragmentation
Cleared on Nov 14, 2025 as substantially equivalent to K213467 (D.O.R.C. Dutch Ophthalmic Research Center (International), 2022) after a 267-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Nov 14, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K933880 (1994). 69 ancestors in all, the oldest K844373 (1985). No later device cites it as a predicate yet.
- Root · 10 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 6 generations between
- 3 generations backK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- 2 generations backK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- 1 generation backK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- This deviceK250501 System SophiThis AG · 2025
Show all 10 generations
- Root · 10 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 9 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 8 generations backK964074 Diolite 532Iriderm Div. · 1997
- 7 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 6 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 5 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 4 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 3 generations backK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- 2 generations backK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- 1 generation backK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- This deviceK250501 System SophiThis AG · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −9 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −8 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −7 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −6 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −5 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −4 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −3 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| −2 | 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 |
| 0 (this device) | 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 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 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 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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? (1)
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 |
|---|---|---|---|
| * | K213467 | EVA NEXUS Ophthalmic Surgical SystemSummary page 5…Classification Panel: Ophthalmic 5 Legally Marketed Predicate Device Device name: EVA NEXUS Ophthalmic Surgical System 510(k) number: K213467 Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International) B.V 6 Predicate Device Description Th… | 2022 |
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 9 companies; a new generation was cleared every 3.4 years on median.
- 20 of the 69 ancestors have a recall of any class.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 System Sophi is an integrated phacoemulsification lens removal device designed for use in intraocular ophthalmic surgery in the anterior chamber. System Sophi is intended for liquid irrigation and aspiration, lens fragmentation and ultrasonic phacoemulsification, anterior vitrectomy, and bipolar diathermy (high frequency surgical equipment).
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/K250501 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250501: System Sophi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250501
Report an extraction error
Are you the manufacturer?
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