# K053333: Eaglevision Gellanserts, Model Ref 0040

- Pathway: 510(k) (Traditional)
- Applicant: Eagle Vision, Inc.
- Decided: May 2, 2006 after 152 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: 2 generations back to K890919 (1989). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K850649: Absorbable Intracanalicular Collagen Implant, Lacrimedics, Inc. (1985) Summary page 1.
- K890919: Temporary Intracanalicular Collagen Implant, Eagle Vision, Inc. (1989) Summary page 1.
- K895342: Collagen Implants for the Lacrimal Efficiency Test, Lacrimedics, Inc. (1989) Summary page 1.
- K897190: Look Temporary Intracanalicular Collagen Implant, Look, Inc. (1990) Summary page 1.
- K946357: Collagen Intracanalicular Plug, Oasis Medical, Inc. (1995) Summary page 1.
- K013613: Soft Plug Absorbable Plug-SA, Oasis Medical, Inc. (2002) Summary page 1.
- K020882: Sharpoint Ultraplug Extended Wear Plug, Surgical Specialties Corp (2002) Summary page 1.
- K022043: Smart Plug, Model 500; Smartplug Forceps, Model 502; Push Rod, Model 503, Medennium, Inc. (2002) Summary page 1.
- K030300: Opaque Herrick Lacrimal Plug, Lacrimedics, Inc. (2003) Summary page 1.

## Indications for use
The EagleVision Gellansert Tm is intended to temporarily block tear drainage by the occlusion of the canaliculus in order to: Determine the potential effectiveness of permanent occlusion, Temporarily treat dry eye syndrome, and the dry eye components of various ocular surface diseases, Increase retention of ocular medications Temporarily treat contact lens intolerance secondary to dry eye, and Treat dry eye after surgery.

Source page: https://510kreport.com/device/K053333
Methodology: https://510kreport.com/methodology