# K971164: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Vision Care, Ltd.
- Decided: May 21, 1997 after 51 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 K951893 (1995). 2 ancestors in all.
14 later devices descend from it; 3 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)
- K951893: Lifestyle 55 (Ocufilcon D) Hydrophilic Contact Lens Lifestyle Frequency 55 (Ocufilcon D) Ghydrophilic Contact Lens, Permeable Technologies, Inc. (1995). Our OCR of the scanned summary read K851893, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “LifeStyle FREQUENCY Progressive (methafilcon A) Hydrophilic…”.
- K963011: Lifestyle Frequency Progressive (Methafilcon a) Multifocal Hydrophilic Contact Lenses for Daily Wear, Permeable Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K973063: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear (1997), 12 descendants of its own
- 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

## 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/K971164
Methodology: https://510kreport.com/methodology