# K984436: PVS Basics

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Vision Sciences
- Decided: Apr 21, 1999 after 128 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.
2 later devices descend from it; 2 cite 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)
- 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.

## Most influential descendants
- K021752: FP (Hexafocon a)RGP Contact Lens Spherical/Asp (Hexafocon a)RGP Contact Lens Aspherical (2002), 0 descendants of its own
- K013310: PVS Basic 2; Epic 2 (2002), 0 descendants of its own

## Indications for use
The PVS BASICS ™ (paflufocon E) rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The PVS BASICS ™ (paflufocon E) 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. PVS BASICS ™ (paflufocon E) toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS BASICS ™ 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.

Source page: https://510kreport.com/device/K984436
Methodology: https://510kreport.com/methodology