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 Dec 14, 2021 as substantially equivalent to K170655 (Mynosys Cellular Devices, Inc., 2017) after a 270-day review. Its family tree reaches back 2 generations to 2000. 2 later devices descend from it.
- Decided
- Dec 14, 2021
- Review
- 270 days
- Class
- Class II
- Product code
- PUL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001498 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK001498 The Fugo BladeMedisurg, Ltd. · 2000 · Recalled
- 1 generation backK170655 ZeptoMynosys Cellular Devices, Inc. · 2017
- This deviceK210827 ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK223763 ZeptoLink IOL Positioning SystemCentricity Vision, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK221188 ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc. · 2022
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 |
|---|---|---|---|---|---|
| −2 | K001498 | The Fugo Blade | Medisurg, Ltd. | 2000 | 1 |
| −1 | K170655 | Zepto | Mynosys Cellular Devices, Inc. | 2017 | — |
| 0 (this device) | K210827 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | 2021 | — |
| +1 | K223763 | ZeptoLink IOL Positioning System | Centricity Vision, Inc. | 2023 | — |
| +1 | K221188 | ZEPTO Precision Capsulotomy System | Centricity Vision, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 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 K223763 ZeptoLink IOL Positioning Systemscore 5.8 · 3 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 |
|---|---|---|---|
| * | K170655 | ZeptoSummary page 4…886.4100 - Apparatus, Cutting, Radiofrequency, Electrosurgical, AC-Powered ZEPTO PUL K170655 6/2/2017 K210827 Page 1 of 4 Devi… | 2017 |
What descends from it? (2)
2 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 3 companies; a new generation was cleared every 16.8 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K223763 (Centricity Vision, Inc., 2023) has gone furthest, with 0 descendants of its own.
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. 2021, 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/K210827 · printed Nov 5, 2026
Cite this page
510(k) Report. “K210827: ZEPTO Precision Capsulotomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K210827
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