# K122220: Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye SH Soft K Toric S

- Pathway: 510(k) (Traditional)
- Applicant: Soflex Limited
- Decided: Mar 19, 2013 after 237 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K133403: Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses, Firesoft-49G Daily Wear Contact Lens (2014), 0 descendants of its own

## Indications for use
The Eni-Eye SH Soft K Semi Scieral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system. Eni-Eye SH Soft K Toric Semi Scleral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 5.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system.

Source page: https://510kreport.com/device/K122220
Methodology: https://510kreport.com/methodology