# K170655: Zepto

- Pathway: 510(k) (Traditional)
- Applicant: Mynosys Cellular Devices, Inc.
- Decided: Jun 2, 2017 after 91 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: 1 generation back to K001498 (2000). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K001498: The Fugo Blade, Medisurg, Ltd. (2000) Summary page 4.

## Most influential descendants
- K210827: ZEPTO Precision Capsulotomy System (2021), 2 descendants of its own
- 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
Zepto70 is indicated for use in performing anterior capsulotomy during cataract surgery.

Source page: https://510kreport.com/device/K170655
Methodology: https://510kreport.com/methodology