# K033969: Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker

- Pathway: 510(k) (Traditional)
- Applicant: Vistakon
- Decided: Feb 4, 2004 after 44 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: 2 generations back to K010114 (2001). 2 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024177: Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker, Johnson & Johnson Vision Care, Inc. (2003) 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)

## Most influential descendants
- 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
- K211448: Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (2021), 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
- K141670: Acuvue (Etafilcon a) Soft Contact Lens for Presbyopia (2014), 1 descendant of its own

## Indications for use
The ACUVUE® 2 COLOURS Contact Lenses are indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. ACUVUE ® 2 COLOURS contact lenses are available in 0.OOD for those patients who do not need vision correction but desire the cosmetic benefits of opaque or enhancer cosmetic contact lenses. The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens is indicated for daily wear 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 of astigmatism or less. The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC Contact Lens is indicated for daily wear 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 of astigmatism or less. The ACUVUE® 2 COLOURS (etafilcon A) Soft (hydrophilic) TORIC-BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less. ACUVUJE® 2 COLOURS UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The ACUVUE 2 COLOURS Contact Lenses may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

Source page: https://510kreport.com/device/K033969
Methodology: https://510kreport.com/methodology