# K000384: Frequency 55, Frequency 55 Aspheric, Encore, Encore Toric, Oneview, Cooperflex

- Pathway: 510(k) (Special)
- Applicant: CooperVision, Inc.
- Decided: Mar 6, 2000 after 28 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K020193: Ocular Sciences, Inc. Biomedics UV Asphere (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2002), 11 descendants of its own
- K091339: Biomedics (Ocufilcon D) Soft (Hydrophilic) Contact Lens (2010), 9 descendants of its own
- K181232: Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia (2018), 3 descendants of its own
- K182523: Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (2018), 2 descendants of its own
- K182247: ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) (2018), 2 descendants of its own

Source page: https://510kreport.com/device/K000384
Methodology: https://510kreport.com/methodology