# K010114: Acuvue 2 Brand (Etafilcon a) Contact Lens, with UV Blocker Tinted (to Mask or Enhance the Natural Iris Color)

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Vision Care, Inc.
- Decided: Apr 11, 2001 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
No predicates in its family tree.
24 later devices descend from it; 7 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013973: Acuvue Brand (Etafilcon a) Soft (Hydrophilic) Contact Lenses; Clear and Tinted (Visibility and/or Cosmetic) with UV Bloc (2002), 16 descendants of its own
- K051900: Acuvue (Etafilcon a) Contact Lens, Clear and with Visibility Tint with UV Blocker, for Daily Wear (2005), 14 descendants of its own
- K024177: Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker (2003), 9 descendants of its own
- K033969: Acuvue 2 Colours Brand (Etafilcon a) Soft (Hydrophilic) Contact Lens with UV Blocker (2004), 8 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

Source page: https://510kreport.com/device/K010114
Methodology: https://510kreport.com/methodology