# K052983: Fluoroperm 151 (Paflufocon D) and Paragon HDS 100 (Paflufocon D) Rigid Gas Permeable Contact Lenses

- Pathway: 510(k) (Traditional)
- Applicant: Paragon Vision Sciences
- Decided: Feb 10, 2006 after 109 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)
- P820065: Boston Lens (R) Lens - Clear, Polymer Technology Corp.. FDA lists this PMA only through its supplements; the earliest we hold is P820065/S001 (Dec 23, 1983). Summary page 1.

## Indications for use
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas pernicale bifocal, or ltric contact lenses are indicated for daily wear only. FluoroPerm® 92 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPermn92 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm ® 92 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm ® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm ® 60 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm ® 60 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm ®60 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 60 bifocal lenses are indicated to treat presbyopia up to 14.00 [ add power. Paragon HDS ® rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I 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 nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HDS ® contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. 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. FluoroPermr 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. FluoroPerm® 30 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes thuF ire nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm ® 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. 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 nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin T contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin T"toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin MT bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. FluoroPerm® 151 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Fluorol~erm~ 151]rigid gas permecab le spherical, aspheric and bifocal contact lenses are indicated for the correction of visualIacuity in not-aph akic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm" 15 1 contact lenses are indicated for persons requiring keratoconus managemrent with otherwise non-diseased eyes, daily wear application only. Fluorol~erm® 151 toric contact lenses are indicated to correct astigmatism up to 6.00 diopters. Fluorcopernn® 151 bifocal lenses are indicated to treat presbyopia up to 4+4.00 D add power. Paragon FI)S®' 100 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear and extended wear from I to 7 days between removals for cleaning anid 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. Parag-on HDS®~ 100 rigid gas permeable spherical, aspheric anid bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (hyperopic), anid may exhibit corneal astigmtatism up to 4.00 diopters that does not interfere with visual acuity. Paragon HIDS" 100 contact lenses are indicated for persons requiring, keratoconus management with otherwise non-diseased eyes, daily wear application only. Paragon HOS® 100 toric contact lenses are indicated to correct astigmatism Of uip to 6.00 diopters. Paragon HDS®' 100 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Source page: https://510kreport.com/device/K052983
Methodology: https://510kreport.com/methodology