# K082799: HDS HI 1.54

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Vision Sciences
- Decided: Jan 27, 2009 after 126 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)
- None. The FDA summary names its predicate without a number.
- (no number) FluoroPerm 30 (paflufocon c): named in the summary without a submission number

## Indications for use
HDS HI 1.54TM rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. HDS HI 1.54TM rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of refractive ametropia in not-aphakic persons with non-diseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. HIDS HI 1.54TM toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. HDS HI 1.54TM bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. HDS HI 1.54TM contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery, in otherwise non-diseased eyes.

Source page: https://510kreport.com/device/K082799
Methodology: https://510kreport.com/methodology