# K122575: Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb Purevision Toric (Balafilcon a) VI

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Dec 20, 2012 after 119 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: 1 generation back to K972454 (1997). 1 ancestor in all.
10 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972454: Oxycor (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb, Inc. (1997) Summary page 1.

## Most influential descendants
- K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia, (2013), 9 descendants of its own
- K223397: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (2024), 1 descendant of its own
- K223585: Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (2023), 1 descendant of its own
- K143632: Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens (2015), 1 descendant of its own
- K261812: HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens; HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens (2026), 0 descendants of its own

## Indications for use
The BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.000 to -20.00D for daily wear. The BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.000 to -20.000 for daily wear. FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned Replacement Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system. DISPOSABLE WEAR When prescribed for Disposable Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is to be discarded after each removal.

Source page: https://510kreport.com/device/K122575
Methodology: https://510kreport.com/methodology