# K190210: Tear Pool Dissolvable Punctum Plugs

- Pathway: 510(k) (Traditional)
- Applicant: Alphamed, Inc.
- Decided: Oct 24, 2019 after 262 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: 1 generation back to K030300 (2003). 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)
- K030300: Opaque Herrick Lacrimal Plug, Lacrimedics, Inc. (2003) Summary page 4.

## Indications for use
Tear Pool Dissolvable Punctum Plugs are designed to provide for temporary occlusion of the tear drainage system. Punctum Plugs are indicated for: * As a diagnostic aid to determine the potential effectiveness of long term occlusion * To temporarily enhance the efficacy of topical medications or ocular lubricants * After ocular surgery to prevent complications due to dry eyes * To evaluate treatment of ocular dryness * To evaluate the dry eye component of ocular surface diseases

Source page: https://510kreport.com/device/K190210
Methodology: https://510kreport.com/methodology