# K122213: Eni-Eye SH Sphere (Efrofilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Soflex Limited
- Decided: Dec 12, 2012 after 140 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Eni-Eye SH Sphere (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons.

Source page: https://510kreport.com/device/K122213
Methodology: https://510kreport.com/methodology