# K974408: Proclear (Omafilcon a) Daily Wear Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles Eyewear, Inc.
- Decided: Apr 16, 1998 after 143 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.
10 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Proclear (omafilcon A) Contact Lens: named in the summary without a submission number

## Most influential descendants
- K061948: Proclear (Omafilcon a) Daily Disposable/Daily Wear Soft Contact Lens (2006), 9 descendants of its own
- K110099: Proclear Toric XR Soft (Hydrophilic) Contact Lens; Proclear Multifocal XR Soft (Hydrophilic) Contact Lens; Proclear Mult (2011), 7 descendants of its own
- K112302: Proclear Toric XR, Proclear Multifocal XR, Proclear Multifocal Toric, Proclear Sphere & Asphere, Toric Contact Lenses (2011), 6 descendants of its own
- K162223: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) (2017), 4 descendants of its own
- K180985: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (2018), 1 descendant of its own

## Indications for use
(omafilcon A) Soft Hydrophilic Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren’s only).

Source page: https://510kreport.com/device/K974408
Methodology: https://510kreport.com/methodology