# K210827: ZEPTO Precision Capsulotomy System

- Pathway: 510(k) (Traditional)
- Applicant: Centricity Vision, Inc.
- Decided: Dec 14, 2021 after 270 days
- Product code: PUL (Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K001498 (2000). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170655: Zepto, Mynosys Cellular Devices, Inc. (2017) Summary page 4.

## Most influential descendants
- K223763: ZeptoLink IOL Positioning System (2023), 0 descendants of its own
- K221188: ZEPTO Precision Capsulotomy System (2022), 0 descendants of its own

## Indications for use
ZEPTO Precision Capsulotomy System is indicated for use in performing anterior capsulotomy during cataract surgery.

Source page: https://510kreport.com/device/K210827
Methodology: https://510kreport.com/methodology