# K120028: Aquamax (Etafilcon a) Disposable Soft Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Pegavision Corporation
- Decided: Apr 17, 2012 after 104 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: 3 generations back to K962804 (1996). 4 ancestors in all.
10 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker, Vistakon, Johnson & Johnson Vision Products, Inc. (1996) Summary page 3.
- K083288: Discon Plus (Etafilcon a) Contact Lens Visibility Tint with UV Blocker, Innova Vision, Inc. (2009) Summary page 3.

## Most influential descendants
- K161739: Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (2016), 6 descendants of its own
- K200296: Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses (2020), 4 descendants of its own
- K211448: Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (2021), 2 descendants of its own
- K140025: Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses (2014), 2 descendants of its own
- K232839: Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (2024), 1 descendant of its own

## Indications for use
1. PEGAVISION Aquamax (Etafilcon A) Daily Disposable Soft (Hydroplil) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.OOD) to -12.OOD. Eye Care Practitioners may prescribe the lens for single-use daily disposable wear. 2. PEGAVISION Aquarm (Etafflcon A) Bi-weeldy Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from 0.OOD to -12.OOD. Eye Care Practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed 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.

Source page: https://510kreport.com/device/K120028
Methodology: https://510kreport.com/methodology