# K013973: Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted (Visibility and/or Cosmetic) with UV Bloc

- Pathway: 510(k) (Traditional)
- Applicant: Vistakon
- Decided: Feb 26, 2002 after 85 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.
16 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994324: Acuvue (Etafilcon a) Soft (Hydrophilic) Contact Lens Clear and Visibility Tinted with UV Blocker, Vistakon, Johnson & Johnson Vision Products, Inc. (2000) Summary page 1.
- K010114: Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color), Johnson & Johnson Vision Care, Inc. (2001) Summary page 1.

## Most influential descendants
- K051900: Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear (2005), 14 descendants of its own
- K062614: Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) (2006), 7 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
- K141917: Unicon (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear (2014), 3 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

## Indications for use
The ACUVUE® Brand Contact Lens (spherical) are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D or less of astigmatism. The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D or less of astigmatism. The ACUVUE® Brand (etafilcon A) Soft (hydrophilic) TORIC BIFOCAL Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye for lenses with cosmetic tint and for the correction of distance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less. ACUVUE® Brand (etafilcon A) Soft (hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. Eye Care Practitioners may prescribe the lens for single-use disposable wear (See “Wearing Schedule”).

Source page: https://510kreport.com/device/K013973
Methodology: https://510kreport.com/methodology