# K102557: Novakone Spherical and Toric Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Alden Optical Labs., Inc.
- Decided: Apr 26, 2011 after 231 days
- Product code: LPL (Lenses, Soft Contact, Daily Wear)
- Device class: 2
- Regulation: 21 CFR 886.5925
- Recalls of this device: 2 (0 Class I)
- 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.

## Recalls of this device
- Nov 3, 2017 · Class II · Z-0981-2018: Contact lenses lack sterility assurance.
- Nov 3, 2017 · Class II · Z-0982-2018: Contact lenses lack sterility assurance.

## Indications for use
The NOVAKONE SPHERICAL lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) in aphakic and not aphakic persons with otherwise non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The NOVAKONE TORIC lens is indicated for daily wear for persons requiring keratoconus management for the correction of refractive ametropia (myopia, hyperopia) and astigmatism in aphakic and not aphakic persons with otherwise non-diseased eyes and who possess refractive astigmatism not exceeding 10 Diopters. The lenses may be prescribed for either conventional wear or planned replacement modalities, and may be disinfected with a chemical or heat disinfection system.

Source page: https://510kreport.com/device/K102557
Methodology: https://510kreport.com/methodology