# K050948: Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens

- Pathway: 510(k) (Abbreviated)
- Applicant: Bausch & Lomb, Inc.
- Decided: May 18, 2005 after 33 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 K960926 (1996). 5 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 19 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.
- P980006: Pure Vision Visibility Tinted Contact Lens for Extended Wear, Bausch & Lomb, Inc. (1999) Summary page 1.
- K020927: Bausch & Lomb Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens, Bausch & Lomb (2002) Summary page 2.

## 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
- K132715: Bausch + Lomb Bioture Oneday for Presbyopia (Nesofilcon a) Contact Lens (2013), 3 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
- K210975: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (2021), 1 descendant of its own

## Indications for use
BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia 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 provides a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.OOD. Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The 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 professional. The lens may be disinfected using a chemical disinfection system. FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned Replacement Wear, the PureVision™ Multi-Focal 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 professional. The lens may be disinfected using a chemical disinfection system. DISPOSABLE WEAR When prescribed for Disposable Wear, the PureVision™ Multi-Focal Contact Lens is to be discarded after each removal.

Source page: https://510kreport.com/device/K050948
Methodology: https://510kreport.com/methodology