# K954124: O-Perm 30 a Rigid Gas Permeable Contact Lens

- Pathway: 510(k) (Traditional)
- Applicant: Optical Polymer Research, Inc.
- Decided: Mar 19, 1996 after 200 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 no predicate by number.

## Indications for use
RGP Spherical contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are indicated for daily wear use. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The spherical lenses are being applied for from +12.00 to -20.00 Diopters up to 4.00 Diopters of astigmatism where it does not interfere with visual acuity. RGP Toric contact lenses made from O->PERM 30A (sterafocon A) which contain a visibility tint are also indicated for daily wear. The lenses are indicated for visual acuity in patients with with non-diseased eyes. The toric lenses are being applied for from +12.00 to -20.00 Diopters up to 6.00 Diopters of astigmatism where it does not interfere with visual acuity.

Source page: https://510kreport.com/device/K954124
Methodology: https://510kreport.com/methodology