# K082850: Eye Spheres

- Pathway: 510(k) (Traditional)
- Applicant: Product and Educational Services, LLC
- Decided: Feb 27, 2009 after 151 days
- Product code: HPZ (Implant, Eye Sphere)
- Device class: 2
- Regulation: 21 CFR 886.3320
- 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 K921106 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972661: Eye Sphere, Conformers, Gulden Ophthalmics (1997) Summary page 1.

## Indications for use
Eye Spheres are permanent implants that occupy the eye cavity when it has become necessary to surgically remove the eye (enucleation) or the contents of the eye sac (evisceration) Conformers are temporary devices which maintain the shape of the eye and prevent closure or adhesion during the healing process

Source page: https://510kreport.com/device/K082850
Methodology: https://510kreport.com/methodology