# K060821: Specialeyes 50 and Specialeyes 49 Shpere and Toric Soft Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Specialeyes, LLC
- Decided: May 18, 2006 after 52 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
Longest line of descent: 2 generations back to K964528 (1997). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983773: Benz G-5X (Hioxifilcon a) Soft Daily Wear Contact Lens, Benz Research and Development Corp. (1998) Summary page 2.
- K964528: (Lenses) Benz-G 3X (Hioxifilcon B) Spherical and Toric Soft (Hydrophilic) Contact Lenses in Clear and with a Blue Tint, Benz Research and Development Corp. (1997) Summary page 2.
- K042242: Alden HP (Hioxifilcon B) Sphere & Toric Soft Contact Lenses, Alden Optical Labs., Inc. (2004) Summary page 2.
- K981252: Oxylens (Hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lenss (Clear & Blue Visibility Tinted, Lathe-Cut FR), Alden Optical Labs., Inc. (1998) Summary page 2.
- K953199: Metro 55G Toric & Spherical, Metrosoft, Inc. (1995) Summary page 2.
- K964902: Contact Lenses Metro-G 3X (Hioxifilcon B), Metro Optics of Austin, Inc. (1997) Summary page 2.

## Indications for use
The Special Eyes 59 (hioxifilcon A) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with non-diseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities. The Special Eyes 49 (hioxifilcon B) Sphere and Toric soft contact lenses for daily wear, are indicated for the correction of visual acuity in aphakic and non aphakic persons with non-diseased eyes with myopia or hypercopia, and/or posses refractive astigmatism not exceeding 10 diopters. They are available for either conventional wear or planned replacement modalities.

Source page: https://510kreport.com/device/K060821
Methodology: https://510kreport.com/methodology