# K140025: Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses - Pathway: 510(k) (Traditional) - Applicant: Pegavision Corporation - Decided: Oct 15, 2014 after 282 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: 4 generations back to K962804 (1996). 6 ancestors in all. 2 later devices descend from it; 1 cites it directly. 0 of 9 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K120028: Aquamax (Etafilcon a) Disposable Soft Contact Lenses, Pegavision Corporation (2012) Summary page 7. - K013445: Osprey Spherical and Toric Multifocal Soft Contact Lenses, Florida Optical Engineering, Inc. (2001) Summary page 6. - K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker, Vistakon, Johnson & Johnson Vision Products, Inc. (1996) Summary page 7. ## Most influential descendants - K150385: NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (2015), 1 descendant of its own - K173086: NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (2017), 0 descendants of its own ## Indications for use 1. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Spherical and Aspheric Aquamax (Etafilcon A) SPHERE and ASPHERE Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric Aquamax (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal Aquamax (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric Aquamax (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less. Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. 2. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement (Replacement Recommended Every 2 Weeks): Spherical and Aspheric Aquamax (Etafilcon A) SPHERE and ASPHERE Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric Aquamax (Etafilcon A) Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal Aquamax (Etafilcon A) Multifocal Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric Aquamax (Etafilcon A) Multifocal Toric Soft (Hydrophilic) Contact Lenses for Frequent Replacement are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less. Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses for Frequent Replacement help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. Pegavision recommends up to two week replacement for Etafilcon A lenses, or replacement as recommended by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. 3. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses Spherical and Aspheric NaturalVue (Etafilcon A) Sphere and Asphere Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +20.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Toric NaturalVue (Etafilcon A) Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. Multifocal NaturalVue (Etafilcon A) Multifocal Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric NaturalVue (Etafilcon A) Multifocal Toric Daily Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with non-diseased eyes who may require a reading addition of up to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 10.00 diopters or less. NaturalVue (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are intended for single-use disposable wear. Source page: https://510kreport.com/device/K140025 Methodology: https://510kreport.com/methodology