510(k) · Cleared
ClearedI-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
INTEROJO, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Mar 12, 2015 as substantially equivalent to K080794 (Polyvue Distribution, Inc., 2008) and 1 other predicate after a 168-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Mar 12, 2015
- Review
- 168 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K953807 (1996). 8 ancestors in all, the oldest P780007 (1979). No later device cites it as a predicate yet.
- Root · 3 generations backK953807 Daily Wear Soft (Hydrophilic) Contact LensStephen A. Dunn, Inc. · 1996
- 2 generations backK980818 Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical…Stephen A. Dunn, Inc. · 1998
- 1 generation backK013220 HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear…Poly Vue Technolgies, Inc. · 2001
- This deviceK142766 I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily WearINTEROJO, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K953807 | Daily Wear Soft (Hydrophilic) Contact Lens | Stephen A. Dunn, Inc. | 1996 | — |
| −2 | K980818 | Polyvue, Silver Chord and Unisoft (Methafilcon a) Spherical, Aspherical, Toric… | Stephen A. Dunn, Inc. | 1998 | — |
| −1 | K013220 | HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted… | Poly Vue Technolgies, Inc. | 2001 | — |
| 0 (this device) | K142766 | I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear | INTEROJO, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080794 | Polyvue 55 Single Vision, Toric and Multifocal Soft (Hydrophilic) Contact Lens for Daily…Summary page 6…ubstantially equivalent to the following predicate devices: Predicate devices: • “I-55 (methafilcon A)” By PolyVue Distribution, Inc. 510(k) number; K080794 -Primary Predicate • “HD/HDT, PV/PVT (polymacon)” By PolyVue Technologies, Inc. 510(k) number; K013220… | 2008 |
| * | K013220 | HD/HDT, PV/PVT (Polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, Fully…Summary page 6…istribution, Inc. 510(k) number; K080794 -Primary Predicate • “HD/HDT, PV/PVT (polymacon)” By PolyVue Technologies, Inc. 510(k) number; K013220 Device Description: The I-55 soft contact lenses are hemispherical shells with molded spherical base curves and molded front su… | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 3.6 years on median.
- None of the 8 ancestors has a recall.
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. 2015, 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 I-55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the…
Read the full statement (372 words)
The I-55 (methafilcon A) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in
aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who
exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The
lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon A) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in
aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive
astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the
apparent color of the eye.
The I-55 (methafilcon A) Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in
aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons
who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity.
The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.
The I-55 (methafilcon A) Toric-Multifocal Soft Contact Lenses for daily wear are indicated for the correction of visual
acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia, possesses refractive
astigmatism not exceeding 5.00 diopters and are presbyopic. The lens is available clear or tinted and may be used to
enhance or alter the apparent color of the eye.
Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in
consultation with their patients.
Frequent/Planned Replacement Wear:
Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning
disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be
disinfected using a chemical disinfecting system.
Disposable Wear:
Eyecare practitioners may prescribe any of the above lenses for single use Daily Disposable Wear. When Prescribed for
Daily Disposable Wear the lens is to be discarded after each removal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142766: I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142766
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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