# K973063: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Vision Care, Ltd.
- Decided: Aug 26, 1997 after 8 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951893 (1995). 3 ancestors in all.
12 later devices descend from it; 4 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971164: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens, Aspect Vision Care, Ltd. (1997) Summary page 1.

## Most influential descendants
- K013649: Sauflon 55 UV Soft (Hydrophilic) Contact Lens (2001), 7 descendants of its own
- K982997: Frequency 55 UV (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted with UV Blocker) (1999), 6 descendants of its own
- K020392: Frequency 55 UV (Methafilcon a) Soft (Hydrophlic) Contact Lens for Daily Wear (2002), 3 descendants of its own
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (2018), 2 descendants of its own
- K133735: Eye Secret 55 UV Aspheric (Methafilcon a) Soft (Hydrophilic) Contact Lens (2014), 1 descendant of its own

## Recalls of this device
- Jun 25, 2003 · Not classified · Z-0978-03: The actual sphere power of the lens is lower than the labeled value.

## Indications for use
The FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K973063
Methodology: https://510kreport.com/methodology