# K181558: Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Gelflex Laboratories
- Decided: Sep 6, 2018 after 85 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 P820021 (1983). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051095: 55 UV (Methafilcon a) Soft (Hydrophilic) Contact Lens for Daily Wear, Optical Connection, Inc. (2005) Summary page 5.
- P820021: Softcon (Vifilcon a) Soft Contact Ext Wear Lens, Alcon Laboratories, Inc. (1983) Summary page 5.
- K001090: Methafilcon a, CooperVision, Inc. (2000) Summary page 5.

## Indications for use
The Sofclear Enhance, Colors, and Comfort (methafilcon A) contact lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye. Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients. Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system. Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

Source page: https://510kreport.com/device/K181558
Methodology: https://510kreport.com/methodology