# K980634: Frequency UV (Etafilcon a) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted)

- Pathway: 510(k) (Traditional)
- Applicant: Aspect Vision Care, Ltd.
- Decided: Apr 22, 1998 after 62 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 K962804 (1996). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962804: Acuvue (Etafilcon a) Contact Lens Clear & W/Visibility Tint W/UV Blocker, Vistakon, Johnson & Johnson Vision Products, Inc. (1996) Summary page 1.

## Most influential descendants
- K030167: Mieru (Etafilcon a) Daily Wear Contact Lens Clear and Visibility Tint, with UV Blocker (2003), 6 descendants of its own
- K052290: Aquasoft All-Day & All-Day T (Hioxifilcon a) Daily Wear Contact Lens (2006), 5 descendants of its own
- K080632: CLEAR1-Day Hioxifilcon Daily Disposable Soft Contact Lens (2008), 3 descendants of its own
- K102895: One Day Flat Pack (2011), 1 descendant of its own
- K192129: ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens (2019), 0 descendants of its own

## Indications for use
The FREQUENCY ™ UV (etafiican A) Hydrophilic Contact Lens {clear and aqua visibility tinted) is indicated for daily wear for the corraction of refractive ametropia (myopia and hyperopia) and astigmatism 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-iens-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/K980634
Methodology: https://510kreport.com/methodology