# K013445: Osprey Spherical and Toric Multifocal Soft Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Florida Optical Engineering, Inc.
- Decided: Dec 26, 2001 after 70 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) UltraVue/P and UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lenses: named in the summary without a submission number

## Most influential descendants
- K140025: Aquamax (Etafilcon a) BI-Weekly Disposable Soft (Hydrophilic) Contact Lenses (2014), 2 descendants of its own
- K150385: NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (2015), 1 descendant of its own
- K173086: NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses (2017), 0 descendants of its own

## Indications for use
The OSPREY Spherical (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia. The lenses may be worn by persons with astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The OSPREY Toric (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia and astigmatism of 4.5 diopters or less.

Source page: https://510kreport.com/device/K013445
Methodology: https://510kreport.com/methodology