# K982774: Soft (Hydrophilic) Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Cl-Tinters
- Decided: Sep 2, 1998 after 26 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: 2 generations back to K951893 (1995). 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)
- K971164: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens, Aspect Vision Care, Ltd. (1997) Summary page 1.

## Indications for use
The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (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. These lenses may be used to enhance or alter the apparent color of the eye, 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/K982774
Methodology: https://510kreport.com/methodology