# K993586: Sportsight GP

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Vision Sciences
- Decided: May 22, 2000 after 213 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
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)
- P820063: Paraperm O2 Contact Lens, CooperVision, Inc.. FDA lists this PMA only through its supplements; the earliest we hold is P820063/S002 (Dec 23, 1983). Summary page 2.

## Indications for use
The SportSight GP (paflufocon C) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The SportSight GP (paflufocon C) rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes who are nearsighted (myopic), farsighted (hyperopic) and who may exhibit corneal astigmatism up to 4.00 diopters or less that does not interfere with visual acuity. SportSight GP (paflufocon C) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. SportSight GP bifocal lenses are indicated for presbyopic persons (far or near sighted) including astigmatic corrections up to +4.00 D requiring add power of up to + 4.00 D. SportSight GP (paflufocon C) contact lenses are indicated for the attenuation of bright light and the reduction of glare. SportSight ™ Gp (paflufocon C) contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Source page: https://510kreport.com/device/K993586
Methodology: https://510kreport.com/methodology