# K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Contamac, Ltd.
- Decided: Mar 19, 2004 after 127 days
- Product code: HQD (Lens, Contact (Other Material) - Daily)
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K942365 (1994). 8 ancestors in all.
28 later devices descend from it; 5 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970698: Boston ES Multivision (Enflufocon a) Contact Lens, Polymer Technology Corp. (1997) Summary page 2.
- K000795: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 2.
- K002025: Rigid Gas Permeable Contact Lens, Polymer Technology (2000) Summary page 2.
- K940277: Paflufocon a, B, C & D, Paragon Vision Sciences (1994) Summary page 2.
- K990264: Comfortkone, Keratoconus Aspheric, Rigid Gas Permeable (RGP), Daily Wear Contact Lens, Metro Optics of Austin, Inc. (1999) Summary page 2.

## Cited in the summary but kept off the family tree
- P870024: Fluoroperm RGP Contact Lenses, CooperVision, Inc. (1987). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K153066: BostonSight IC Corneal Lens, BostonSight IC Scleral Lens (2016), 20 descendants of its own
- K161461: BostonSight PD Prosthetic Device (2016), 19 descendants of its own
- K171404: BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B) (2017), 14 descendants of its own
- K180616: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens (2018), 9 descendants of its own
- K161100: Optimum GP with HPT (roflufocon A, B, C, D, and E) Daily Wear Contact Lenses (2016), 8 descendants of its own

## Recalls of this device
- Jul 3, 2018 · Class III · Z-2982-2018: Vials labeled for the prescriptions contained incorrect lenses
- Jul 3, 2018 · Class III · Z-2981-2018: Vials labeled for the prescriptions contained incorrect lenses

## Indications for use
The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Spherical Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Torie Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Multifocal/Bifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Keratoconus Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K033594
Methodology: https://510kreport.com/methodology