# K050157: Maxsight (Polymacon) Sport-Tinted Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Bausch & Lomb, Inc.
- Decided: Apr 26, 2005 after 91 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K961895: Flexilog LS 13921, Oakfield Instruments, Ltd. (1996). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K192225: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses (2019), 0 descendants of its own

## Indications for use
The MAXSIGHT (polymacon) Sport-Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in 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 in spherical powers ranging from +20.00 to -20.00 diopters. The MAXSIGHT (polymacon) Sport-Tinted contact lens helps protect against the transmission of harmful UV radiation to the comea and into the eye. Replacement schedules may vary from patient to patient, and should be decided by eye care professionals 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 professionals. The lens may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K050157
Methodology: https://510kreport.com/methodology