510(k) · Cleared
ClearedQuatera 700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Carl Zeiss Meditec, AG · HQC Unit, Phacofragmentation
Cleared on Jul 31, 2023 as substantially equivalent to K212241 (Carl Zeiss Meditec, AG, 2022) after a 124-day review. Its family tree reaches back 9 generations to 1994.
- Decided
- Jul 31, 2023
- Review
- 124 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K933880 (1994). 55 ancestors in all, the oldest K844373 (1985). No later device cites it as a predicate yet.
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 5 generations between
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- 1 generation backK212241 Quatera 700Carl Zeiss Meditec, AG · 2022
- This deviceK230858 Quatera 700Carl Zeiss Meditec, AG · 2023
Show all 9 generations
- Root · 9 generations backK933880 SL Series Surgical Laser SystemsLaserscope · 1994
- 8 generations backK954905 CB Diode/532 Laser SystemContinuum Biomedical, Inc. · 1996
- 7 generations backK964074 Diolite 532Iriderm Div. · 1997
- 6 generations backK982031 Oculight GL with the Dermatology HandpieceIridex Corp · 1998
- 5 generations backK031665 Iris Medical Oculight GL/GLX Laser SystemsIridex Corp · 2003
- 4 generations backK062624 Next Generation LaserAlcon Laboratories · 2007
- 3 generations backK101285 Constellation Vision SystemAlcon Manufacturing, Ltd. · 2010 · Recalled
- 2 generations backK142877 EVA,anterior machine, EVA, combined machine, EVA combined machine…Dutch Ophthalmic Research Center International BV · 2015
- 1 generation backK212241 Quatera 700Carl Zeiss Meditec, AG · 2022
- This deviceK230858 Quatera 700Carl Zeiss Meditec, AG · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933880 | SL Series Surgical Laser Systems | Laserscope | 1994 | — |
| −8 | K954905 | CB Diode/532 Laser System | Continuum Biomedical, Inc. | 1996 | — |
| −7 | K964074 | Diolite 532 | Iriderm Div. | 1997 | — |
| −6 | K982031 | Oculight GL with the Dermatology Handpiece | Iridex Corp | 1998 | — |
| −5 | K031665 | Iris Medical Oculight GL/GLX Laser Systems | Iridex Corp | 2003 | — |
| −4 | K062624 | Next Generation Laser | Alcon Laboratories | 2007 | — |
| −3 | K101285 | Constellation Vision System | Alcon Manufacturing, Ltd. | 2010 | 4 |
| −2 | K142877 | EVA,anterior machine, EVA, combined machine, EVA combined machine with laser… | Dutch Ophthalmic Research Center International BV | 2015 | — |
| −1 | K212241 | Quatera 700 | Carl Zeiss Meditec, AG | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K212241 | Quatera 700Summary page 6…VALENCE 6.1. Primary Predicate Table 1. Subject to Predicate Device Comparison Table – Indications for Use Subject Device Predicate Device (K212241) Equivalency Analysis QUATERA 700 is intended for Q… | 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 29 years and passes through 8 companies; a new generation was cleared every 3.0 years on median.
- 16 of the 55 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. 2023, 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?
QUATERA System (QUATERA 700) is intended for the emulsification and removal of cataracts and anterior segment vitrectomy. In combination with various required components and accessories, the device is designed for use in anterior segment surgery. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation and anterior vitrectomy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230858: Quatera 700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230858
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