# K131208: Bausch + Lomb Procomfort (Samfilcon a) Contact Lens, Bausch + Lomb Procomfort (Samfilcon a) Contact Lens for Presbyopia,

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Sep 11, 2013 after 135 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: 3 generations back to K960926 (1996). 7 ancestors in all.
9 later devices descend from it; 6 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122575: Bausch & Lomb Purevision (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb Purevision Toric (Balafilcon a) VI, Bausch & Lomb, Inc. (2012) Summary page 1.
- K050948: Purevision Multi-Focal (Balafilcon a) Visibility Tinted Contact Lens, Bausch & Lomb, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K260507: Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus (2026), 0 descendants of its own

## Indications for use
The Bausch + Lomb (samfilcon A) Soft (hydrophilic) 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 +20.00D to -20.00D. The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism 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 +20.00D to -20.00D. The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia 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 may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D. FREQUENT/PLANNED REPLACEMENT WEAR When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia 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 (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.

Source page: https://510kreport.com/device/K131208
Methodology: https://510kreport.com/methodology