# K993252: Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 UV (to BE Marketed YR. 2000), Frequency 55 Asp

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Nov 24, 1999 after 57 days
- Product code: MVN (Lens, Contact, (Disposable))
- 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). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973063: Frequency 55 (Methafilcon a) Hydrophilic Contact Lens for Daily Wear, Aspect Vision Care, Ltd. (1997) Summary page 2.
- 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 2.

## Cited in the summary but kept off the family tree
- K871164: Gluma (TM) Bonding System, Columbus Dental Mfg. Co. (1987). Our OCR of the scanned summary read K871164, FDA’s number for Gluma (TM) Bonding System (Columbus Dental Mfg. Co.), which shares no applicant, product code or review panel with this device, and the summary gives no name to check it against. Kept off the family tree. Summary page 2.

## Most influential descendants
- K181230: Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA (2018), 0 descendants of its own

## Indications for use
Frequency 55, Frequency 55 UV, Frequency 55 Aspheric, Encore, CooperFlex and Onevue 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 usual acuity. Frequency 55 lenses with UV absorbing monomer helps protect against transmission of harmful UV radiation to the cornea and into the eye. Encore Toric lenses are indicated for daily 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. Frequent/Planned Replacement Wear When prescribed for Frequent/Planned Replacement Wear, the Frequency 55, Frequency 55 Aspheric, Frequency 55 UV, Encore, Encore Toric, CooperFlex and Onevue 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 practitoner. 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 to discard the lenses at each removal.

Source page: https://510kreport.com/device/K993252
Methodology: https://510kreport.com/methodology