# K132796: Suntouch Eye Spear

- Pathway: 510(k) (Traditional)
- Applicant: Huizhou Foryou Medical Devices Co., Ltd.
- Decided: Oct 30, 2013 after 54 days
- Product code: HOZ (Sponge, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4790
- 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 K002279 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002279: ML Eye Spear, Model ML 27 ES, Med-Logics, Inc. (2000) Summary page 2.

## Indications for use
The Eye Spears are designed to absorb fluids and remove debris from the operative field or instruments during ophthalmic surgery.

Source page: https://510kreport.com/device/K132796
Methodology: https://510kreport.com/methodology