# K013310: PVS Basic 2; Epic 2

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Vision Sciences
- Decided: Apr 25, 2002 after 203 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 K984436 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984436: PVS Basics, Paragon Vision Sciences (1999) Summary page 2.

## Indications for use
PVS Basic™ 2 and Epic® 2 rigid gas permeable 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 that does not interfere with visual acuity. PVS Basic™ 2 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. PVS Basic™ 2 and Epic® 2 bifocal lenses are indicated for presbyopic persons (farsighted or nearsighted) including astigmatic corrections up to +4.00 D requiring add power of up to +4.00 D.

Source page: https://510kreport.com/device/K013310
Methodology: https://510kreport.com/methodology