# K973192: Flexlens, Flexlens Toric

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Ultravision, Inc.
- Decided: Nov 20, 1997 after 87 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) Flexlens (hefilcon A) Hydrophilic Contact Lens for Daily Wear: named in the summary without a submission number
- (no number) Flexlens Toric (hefilcon A) Hydrophilic Contact Lens for Daily Wear: named in the summary without a submission number

## Indications for use
The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes. Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Source page: https://510kreport.com/device/K973192
Methodology: https://510kreport.com/methodology