# K241229: Hello,eyes® BIO Plug

- Pathway: 510(k) (Traditional)
- Applicant: Bio Optics Co., Ltd.
- Decided: Jun 28, 2024 after 57 days
- Product code: LZU (Plug, Punctum)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K890919 (1989). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162361: Soft Plug Extended Duration 180 Canalicular Plug, Oasis Medical, Inc. (2017) Summary page 4.

## Indications for use
Hello,eyes@ BIO Plug is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to - Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, - Temporarily enhance the efficacy of topical medications or ocular lubricants, - Temporarily treat contact lens intolerance secondary to dry eye, - Temporarily treat dry eye after ocular surgery, and, - Determine the potential effectiveness of permanent occlusion.

Source page: https://510kreport.com/device/K241229
Methodology: https://510kreport.com/methodology