510(k) · Cleared
ClearedEni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye SH Soft K Toric S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soflex Limited · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 19, 2013 after a 237-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Mar 19, 2013
- Review
- 237 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK122220 Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic)…Soflex Limited · 2013
- Descendant · cites it directly · 0 of its ownK133403 Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear…Firestone Optics, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133403Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses…Firestone Optics, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K122220 | Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus… | Soflex Limited | 2013 | — |
| +1 | K133403 | Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact… | Firestone Optics, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LPL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LPL device
- #1 K243868 Pegavision (Toufilcon B) Daily Disposable Soft…score 16.8 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133403 | Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses… | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133403 (Firestone Optics, Inc., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LPL devicesLPL Lenses, Soft Contact, Daily Wear: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LPL
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LPL
202in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LPL
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LPL
216in 2025
MAUDE reports naming product code LPL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 281 | 1 | 280 |
| 2008 | 10 | 104 | 0 | 214 |
| 2009 | 6 | 260 | 1 | 137 |
| 2010 | 9 | 244 | 0 | 222 |
| 2011 | 12 | 170 | 5 | 377 |
| 2012 | 12 | 131 | 1 | 250 |
| 2013 | 17 | 135 | 0 | 151 |
| 2014 | 15 | 102 | 1 | 179 |
| 2015 | 12 | 120 | 1 | 161 |
| 2016 | 21 | 112 | 0 | 193 |
| 2017 | 9 | 98 | 11 | 280 |
| 2018 | 21 | 56 | 0 | 257 |
| 2019 | 11 | 115 | 0 | 205 |
| 2020 | 10 | 158 | 1 | 117 |
| 2021 | 8 | 88 | 0 | 110 |
| 2022 | 9 | 212 | 1 | 126 |
| 2023 | 10 | 167 | 0 | 178 |
| 2024 | 12 | 128 | 0 | 297 |
| 2025 | 12 | 202 | 1 | 216 |
| 2026 | 10 | 90 | 1 | — |
What is it indicated for?
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…
Read the full statement (154 words)
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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K122220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122220: Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye SH Soft K Toric S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122220
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026