# K042824: Frequency 38 and Silver 07 (Polymacon) Soft (Hydrophilic) Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: CooperVision, Inc.
- Decided: Nov 16, 2004 after 35 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 K950283 (1995). 3 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K971049: Frequency 38 (Polymacon) Hydrophilic Contact Lens for Daily Wear (Clear and Tinted), Aspect Vision Care, Ltd. (1997) Summary page 4.

## Most influential descendants
- K123973: Aquamax (Polymacon) Disposable Soft (Hydrophilic) Contact Lenses (2013), 2 descendants of its own
- K182674: Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (2018), 1 descendant of its own
- K132714: Isens (Polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear, Tinted, and Cosmetic Tinted) (2014), 1 descendant of its own
- K242916: Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (2025), 0 descendants of its own
- K142384: DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) (2014), 0 descendants of its own

## Indications for use
Frequency 38 and Silver 07 (polymacon) Soft (hydrophilic) Contact Lenses are 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. Eye care practitioners may prescribe Frequency 38 (polymacon) Soft (hydrophilic) Contact Lenses for frequent replacement wear, with cleaning, disinfecting, and scheduled replacement.

Source page: https://510kreport.com/device/K042824
Methodology: https://510kreport.com/methodology