510(k) · Cleared
ClearedZEPTO Precision Capsulotomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centricity Vision, Inc. · PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Cleared on Jun 23, 2022 as substantially equivalent to K210827 (Centricity Vision, Inc., 2021) after a 59-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jun 23, 2022
- Review
- 59 days
- Class
- Class II
- Product code
- PUL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001498 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001498 The Fugo BladeMedisurg, Ltd. · 2000 · Recalled
- 2 generations backK170655 ZeptoMynosys Cellular Devices, Inc. · 2017
- 1 generation backK210827 ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc. · 2021
- This deviceK221188 ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
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 PUL? 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 PUL device
- #1 K210827 ZEPTO Precision Capsulotomy Systemscore 8.8 · 2 generations · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K210827 | ZEPTO Precision Capsulotomy SystemSummary page 4…Code Number Date ZEPTO Precision 886.4100 - Apparatus, Cutting, Capsulotomy Radiofrequency, Electrosurgical, AC- PUL K210827 12/14/2021 System Powered K221188 Pa… | 2021 |
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 22 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K210827.
How does its category compare?
All PUL devicesPUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PUL
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PUL
Too few PUL 510(k)s in any year since 2007 to give a median.
Recalls per year · PUL
No recall names PUL since 2007.
Adverse event reports per year · PUL
No MAUDE report names PUL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221188: ZEPTO Precision Capsulotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221188
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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