510(k) · Cleared

Cleared

ZeptoLink IOL Positioning System

K223763510(k) TraditionalCleared Apr 11, 2023117-day reviewClass II21 CFR 886.4100

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Centricity Vision, Inc. · PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Cleared on Apr 11, 2023 as substantially equivalent to K210827 (Centricity Vision, Inc., 2021) after a 117-day review. Its family tree reaches back 3 generations to 2000.

Decided: Apr 11, 2023
Review: 117 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.

By dateBy generation

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 deviceK223763 ZeptoLink IOL Positioning SystemCentricity Vision, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K001498	The Fugo Blade	Medisurg, Ltd.	2000	1
−2	K170655	Zepto	Mynosys Cellular Devices, Inc.	2017	—
−1	K210827	ZEPTO Precision Capsulotomy System	Centricity Vision, Inc.	2021	—
0 (this device)	K223763	ZeptoLink IOL Positioning System	Centricity Vision, Inc.	2023	—

FIG. 1 — Lineage of K223763, 2000–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K210827	ZEPTO Precision Capsulotomy System Summary page 4 …Date ZEPTO Precision 886.4100 - Apparatus, Cutting, PUL K210827 12/14/2021 Capsulotomy Radiofrequency, Electrosurgical, AC-Powered System K223763 - Traditional 510…	Centricity Vision, Inc.	2021	—

Also cleared against K210827: 1 other device →

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 23 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 devices

PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · PUL

1in 2023

2007high 1 (2017) · low 0 (2007)2026

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	1	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	1	—	0
2022	1	—	0
2023	1	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The ZeptoLink IOL Positioning System is indicated for use in performing anterior capsulotomy during cataract surgery.

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/K223763 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223763: ZeptoLink IOL Positioning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223763

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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