# K020392: Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Apr 26, 2002 after 79 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: 4 generations back to K951893 (1995). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013649: Sauflon 55 UV Soft (Hydrophilic) Contact Lens, Sauflon Pharmaceuticals, Ltd. (2001) Summary page 1.
- K982997: Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted with UV Blocker), Aspect Vision Care, Ltd. (1999) Summary page 1.

## Most influential descendants
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (2018), 2 descendants of its own
- K243953: Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) (2025), 0 descendants of its own
- K192225: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses (2019), 0 descendants of its own

## Indications for use
1. Frequency 55 UV and Frequency 55 UV Aspheric lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. 2. Frequency 55 UV Toric lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who have astigmatism of 12.00 diopters or less. FREQUENCY 55 LENSES WITH UV ABSORBING MONOMER HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND THE EYE. Note: Only chemical (not heat) and hydrogen peroxide disinfection systems may be used with Frequency 55 UV lenses. Frequent/Planned Replacement Wear When prescribed for Frequent/Planned Replacement Wear, the Frequency 55 UV and Frequency 55 UV Toric lenses are to be cleaned, rinsed and disinfected each time they are removed from the eye and discarded after the recommended wearing period prescribed by the eye care practitioner. Disposable Wear When prescribed for Disposable Wear, the wearing time prescribed by the eye care practitioner is for daily wear (single use). Patients should be instructed fo discard the lenses at each removal.

Source page: https://510kreport.com/device/K020392
Methodology: https://510kreport.com/methodology