# K143280: BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens

- Pathway: 510(k) (Abbreviated)
- Applicant: Brien Holden Vision Pty, Ltd.
- Decided: Apr 23, 2015 after 160 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: 6 generations back to K962804 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062614: Vistakon (Etafilcon a) Soft (Hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically), Johnson & Johnson Vision Care, Inc. (2006) Summary page 4.

## Indications for use
The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of distance, intermediate and near vision in presbyopic, phakic or pseudo-phakic persons with non-diseased eyes who can have up to approximately 1.50 diopters (D) of astigmatism. The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens helps protect against transmission of harmful UV radiation to the cornea and into the eye. 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 single-use disposable wear (see “Wearing Schedule”) the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal. Therefore no cleaning or disinfection is required. When prescribed for frequent/planned replacement wear the BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed, and disinfected each time the lens is removed. The BHV VIVID (etafilcon A) Soft (Hydrophilic) Contact Lens contact lens is to be discarded after the recommended wearing period as prescribed by the eye care practitioner. When prescribed for frequent/planned replacement wear, the lenses should be disinfected using a chemical disinfection system only (i.e., not heat).

Source page: https://510kreport.com/device/K143280
Methodology: https://510kreport.com/methodology