# K120996: Fluoroperm 30 Paragon HDS Fluoroperm 60 Paragon HDS 100 Fluoroperm 92 Fluoroperm 151 Paragon Thin

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Vision Sciences
- Decided: Jun 28, 2012 after 87 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: 5 generations back to K943177 (1994). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053124: Boston ES (Enflufocon a), Boston EO (Enflufocon B) and Boston XO (Hexafocon a) Rigid Gas Permeable Contact Lenses, Bausch & Lomb, Incorporated (2006) Summary page 5.
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens, Bausch & Lomb, Inc. (2007) Summary page 5.
- K070637: Fluoroperm 92, 60, 30 and 151 and Paragon HDS, HDS 100 and Thin Rigid Gas Permeable Contact Lenses, Paragon Vision Sciences (2007) Summary page 5.

## Most influential descendants
- K180172: FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG (2018), 0 descendants of its own

## Indications for use
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Fluoroerm® 92 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only. Fluoroerm® 92 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Fluoroerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Fluoroerm® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Fluoroerm® 92 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. Fluoroerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Fluoroerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Fluoroerm® 60 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Fluoroerm® 60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Fluoroerm® 60 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Fluoroerm® 60 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. Paragon HDS® rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Paragon HDS® 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon HDS® 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. Fluoroerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. Fluoroerm® 30 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Fluoroerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Fluoroerm® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Fluoroerm® 30 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. Paragon Thin™ rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. Paragon Thin™ 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon Thin 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. Fluoroerm® 151 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Fluoroerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Fluoroerm® 151 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Fluoroerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Fluoroerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Fluoroerm® 151 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. Paragon HDS® 100 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. Paragon HDS® 100 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only. Paragon HDS® 100 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS® 100 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon HDS® 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. In daily wear use only, Paragon HDS® 100 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/K120996
Methodology: https://510kreport.com/methodology