# K980197: Ultracon/Ultracon S Rigid Gas Permeable Contact Lens for Daily Wear

- Pathway: 510(k) (Traditional)
- Applicant: Specialty Ultravision, Inc.
- Decided: Aug 4, 1998 after 196 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963010 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963010: Lifestyle GP (Telefocon B) Rigid Gas Permeable Multifocal Contact Lens for Daily Wear, Permeable Technologies, Inc. (1996) Summary page 1.

## Most influential descendants
- K992787: Epicon (Carbosilfocon a) Rigid Gas Permeable Contact Lens Daily Wear (2000), 0 descendants of its own

## Indications for use
The UltraCon and UltraCon S (carbosilfocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 4.00 diopters. The lenses may be disinfected using a chemical disinfection system.

Source page: https://510kreport.com/device/K980197
Methodology: https://510kreport.com/methodology