510(k) · Cleared
ClearedFiresoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses, Firesoft-49G Daily Wear Contact Lens
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Firestone Optics, Inc. · LPL Lenses, Soft Contact, Daily Wear
Cleared on Jun 11, 2014 as substantially equivalent to K122220 (Soflex Limited, 2013) and 4 other predicates after a 217-day review. Its family tree reaches back 6 generations to 1981.
- Decided
- Jun 11, 2014
- Review
- 217 days
- Class
- Class II
- Product code
- LPL
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to P810005 (1981). 20 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backP810005 Weicon (R) (Tefilicon) Hydrophilic Contact LensCiba Vision Care · 1981
- 5 generations backK970746 SEE3 (Lotrafilcon a) Soft Contact LensCiba Vision Corporation · 1997
- 4 generations backK020139 Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal DesignCiba Vision Corporation · 2002
- 3 generations backK033919 Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric…Ciba Vision Corporation · 2004 · Recalled
- 2 generations backK052560 Biofinity (Comfilcon a) Soft Contact LensCooperVision, Inc. · 2005 · Recalled
- 1 generation backK100221 INTELLIWAVE3Art Optical Contact Lens, Inc. · 2010
- This deviceK133403 Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear…Firestone Optics, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | P810005 | Weicon (R) (Tefilicon) Hydrophilic Contact Lens | Ciba Vision Care | 1981 | — |
| −5 | K970746 | SEE3 (Lotrafilcon a) Soft Contact Lens | Ciba Vision Corporation | 1997 | — |
| −4 | K020139 | Focus Excelens (Lotrafilcon B) Spherical, Toric and Multifocal Design | Ciba Vision Corporation | 2002 | — |
| −3 | K033919 | Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal… | Ciba Vision Corporation | 2004 | 1 |
| −2 | K052560 | Biofinity (Comfilcon a) Soft Contact Lens | CooperVision, Inc. | 2005 | 1 |
| −1 | K100221 | INTELLIWAVE3 | Art Optical Contact Lens, Inc. | 2010 | — |
| 0 (this device) | K133403 | Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact… | Firestone Optics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K122220 | Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and…Summary page 11…ireSoft-IC (efrofilecn A) Nt:w Device New Device predicate device, New Device predicate device, New Device predicate device, New Device predicate device, K023589 K031317 K122220 The contact lenses act The cootact lenses act ‘The contact lenses act amexs same as 23 a refractive medium same s ceme s 23 a ref… | 2013 |
| * | K100221 | INTELLIWAVE3Summary page 9…g process (lathe-cut) to the cleared Intelliwave3 (eftofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens cleared under K 10022 1. The FfreSoft-55, (methafilcon A) Hydrogel Daily Wear Soft Contact Lens is identical… | 2010 |
| * | K023989 | Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted…Summary page 9…facturing process (lathe-cut) to the cleared Contaflex-55 (methafilcon A) Hydrogel Daily Wear Soft Contact Lens cleared under K023989. The FireSoft-49G, (hioxifilcon B) Hydrogel Daily Wear Soft Contact Lens is identica… | 2003 |
| * | K091327 | Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54 Toric…Summary page 9…nufacturing process (lathe-cut) to the cleared Alden HP54 (hioxifilcan D) Hydrogel Daily Wear Soft Contact Lens cleared under K091 327. 133403 Page 10 ofl11 Conclusions D… | 2010 |
| * | K981252 | Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue…Summary page 9…nufacturing process (lathe-cut) to the cleared Alden HP49 (hioxifilcon B) Hydrogel Daily Wear Soft Contact Lens cleared under K981252. The FireSoft-54G, (hioxifilcon D) Hydrogel Daily Wear Soft Contact Lens is identica… | 1998 |
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 33 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 6 of the 20 ancestors have a recall of any class.
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. 2014, 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 FireSoft-540 sphere (hioxifilcon D) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity Inaphakic and not aphakic persons with non-diseased eyes with myopia or hyperopla. The lens may be wornt by persons who exhibit refractive astigmatism of .75 diopters; or less where the astigmatism does not interfere with visual acuity. The FireSoft-4U torte (hioxifilcon D)Soft Contact Lenses for daily wear are indicated for the…
Read the full statement (1,015 words)
The FireSoft-540 sphere (hioxifilcon D) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity Inaphakic and not aphakic persons with non-diseased eyes with myopia or hyperopla. The lens may be wornt by persons who exhibit refractive astigmatism of .75 diopters; or less where the astigmatism does not interfere with visual acuity.
The FireSoft-4U torte (hioxifilcon D)Soft Contact Lenses for daily wear are indicated for the correction of visual acuity Inaphakic and not aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 dlopters.
The FireSoft-540 multifocal (hioxifilcon D)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 are presbyopic requiring add power of up to +4.00 diopters.
The FireSoft-540 multifocal toric (hioxifilcon D) Soft Contact Lenses for daily wear are indicated for the correction of annetropia (myopia and hyperopia) in aphaldc and not aphakic persons with non diseased eyes andfor possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement When prescribed for firequent/iplanned replacement wear, the lens may be cleaned and disinfected using achemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The FireSoft-49G sphere (hioxitilcon B) 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 .75 diopters or less where the astigmatism does not interfere with visual acuity,
TheFireSoft-49G tonec (hioxifilcon B) 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 12 diopters.
TheFireSoft-49G multifocal (hioxifilcon B) 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 are presbyopic requiring add power of up to +4.00 diopters.
The FireSoft-49G multifocal tonec (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and not aphakic persons with non diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The FireSoft-IC (efrofilcon A) Soft Contact Lenses, for daily wear are indicated for and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular comneal conditions such as keratoconus and post graft finting.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected wsing a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The FireSoft-SiHy sphere (efrofilcon A) 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 .75 diopters or less where the astigmatism does not interfere with visual acuity.
The FireSoft-Sil-y toric (efrofilcon A) 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 12 diopters.
The FireSoft-SiHy multifocal (efrofilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphalcic persons with non diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.
The FireSoft-SiHy rnultifocal toric (efrofilcon A) Soft Contact Lenses for daily wear are indicated for the correction of arnetropia (myopia and hyperopia) in aphakic and not aphakic persons with non diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecarc practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected wsing a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The FireSoft-55 sphere (niethafilcon A) 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.75 diopters or less where the astigmatism does not interfere with visual acuity.
The FireSoft-55 toric (methafilcon A) 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 12 diopters.
The FireSoft-55 multifocal (methafilcon A) 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 are presbyopic requiring add power of up to +4.00 diopters.
The EireSoft-55 multifocal toric (methafilcon A) Soft Contact Lenses for daily wear are indicated for the correction of amnetropia (myopia and hyperopia) in aphakic and not aphakic persons with non diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequentiplanned replacement wear, the lens may be cleaned and disinfected wing a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133403 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133403: Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses, Firesoft-49G Daily Wear Contact Lens.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133403
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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