# K133403: Firesoft-Sihy. IC Daily Wear Contact Lenses, Firesoft-55 Daily Wear Contact Lenses, Firesoft-49G Daily Wear Contact Lens - Pathway: 510(k) (Traditional) - Applicant: Firestone Optics, Inc. - Decided: Jun 11, 2014 after 217 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 Longest line of descent: 6 generations back to P810005 (1981). 20 ancestors in all. No later device cites it as a predicate yet. 0 of 21 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K122220: Eni-Eye SH Soft K Semi Scleral (Efrofilcon a) Soft (Hydrophilic) Keratoconus and Irregular Cor Eni-Eye SH Soft K Toric S, Soflex Limited (2013) Summary page 11. - K100221: INTELLIWAVE3, Art Optical Contact Lens, Inc. (2010) Summary page 9. - K023989: Contaflex 55 (Methafilcon) Spherical Soft Contact Lens for Daily Wear (Clear and Tinted, Lathe-Cut), Contamac, Ltd. (2003) Summary page 9. - K091327: Alden HP 54 Sphee 7 Hip 54 Toric Contact Lenses, Alden HP 54 Multifocal &HP 54 Toric Multifocal Contact Lenses, Alden Optical Labs., Inc. (2010) Summary page 9. - K981252: Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR), Alden Optical Labs., Inc. (1998) Summary page 9. ## Indications for use 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. Source page: https://510kreport.com/device/K133403 Methodology: https://510kreport.com/methodology