(55 days)
FluoroPerm® 92 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I horor chil. 92 ngla ga permission between removals for cleaning and disinfection as recommended by the eye care practitioner. FluoroPerm® 92 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm® 92 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphabic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 92 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 92 bifocal leases are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 92 contact lenses are indicated for management of irregular corneal conditions such as kerator ones, pellucid marginal degeneration, or following penctrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 60 rigid gas permeable spherical or aspheric contact lenses are indicated for daily wear I tobior and out from 1 to 7 days between removals for cleaning and disinfection as recommonded by the eye care practitioner. FluoroPerm® 60 rigid gas permeable bifocal, or toric contact leases are indicated for daily wear only.
FluoroPerm® 60 rigid gas permeable spheric and bifocal contact leases are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eyes that are nearsighted (myopic), farsighted (byperopic), and may exhibit corneal astigmatism up to 4.00 diopters that does not interfece with visual acuity. FivoroPerm® 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 +4.00 D add power.
FluoroPerm® 60 contact leases are indicated for management of irregular comcal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoriasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon HDS® rigid gas permeable spheric 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 cye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
Paragon HDS rigid gas permeable spherical, asphenc and bifocal contact lenses are indicated for the correction of visual aculty 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. Paragon HDS tone contact leases are indicated to correct astigmatism of up to 6.00 diopters. Faragon HDS® bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
Paragon HDS contact lenses are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratotorny, radial keratotorny, or LASIK surgeryin otherwise nondiseased eyes.
FluoroPerm® 30 rigid gas permeable contact leases are indicated for daily wear as recommended by the eye care practitioner.
FluoroPerm* 30 rigid gas permeable spheric 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 10 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 30 toric contact lenses are indicated to correct astigmatism of up 10 6.00 diopters. FluoroPerm* 30 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm® 30 contact lenses are indicated for management of irregular comeal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
Paragon Thin " rigid gas permeable contact lenses are indicated for daily wear as recommended by the eve care practitioner.
Paragon Thin rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased tyes that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comes astigmatism up to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" witc contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin bifocal lenses are indicated to treat presbyopia up 10 +4.00 D add power.
Paragon Thin" contact lenses are indicated for management of iregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 151 rigid gas permeable spheric 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. FluoroPerme 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.
FluoroPerm 151 rigid gas permeable spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased cycs that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diopters that does not interfere with visual acuity. FluoroPenn® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopers. FluoroPerm 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.
FluoroPerm 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 nondiseased eyes.
Paragon HDS 100 rigid gas permeable spheric 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 spheric and bifocal contact lenses are indicated for the correction of visual scuity in not-aphakic persons with nondiseased eves that are nearsighted (myopic), farsighted (hyperopic), and may exhibit comeal astigmatism up to 4.00 diovers that docs 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.
Paragon HDS 100 contact leases are indicated for management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following peactrating keratoplasty, radial keratotomy, or LASIK surgery in otherwise nondiseased eyes.
FluoroPerm® 92, FluoroPerm® 60, Paragon HDS*, FluoroPerm* 30, Paragon Thin"*, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lath cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; pastufocon A (FluoroPerm" 02), pallufocon B (FluoroPerm) 60, Paragon HDS®), patlufocon C (Fluorosco (Film The Paragon Time), and Poly San Poly San Parised Bron fluorosilicone acrylate monomers.
The lenses may be tinted to offer a handling and for locating the lens. The tinted lenses contain one or more of the following approved color additives: D&C Green No. 6, Peroxide Yellow No. 9, D&C Violet No. 2 and D&C Red No. 17.
The lenses may be available with an ultraviolet absorber (not in all colors and materials). The ultraviolet absorber, Uvinul D-49, has been integrated as an additive within the polymer matrix, blocking up to 97% of light below 380 nm. The UV absorber is 2.2'-dihydroxy-4,4'-dimethoxybenzophenone.
The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspherical curves peripheral to the base curve.
I am sorry, but based on the provided document, I cannot generate the requested information about acceptance criteria and a study proving device performance. The document is primarily a 510(k) clearance letter and an "Indications For Use" statement for various rigid gas permeable contact lenses. It does not contain details about specific acceptance criteria or a study that directly demonstrates the device meets such criteria with performance data, sample sizes, ground truth establishment, or expert involvement.
The document discusses the substantial equivalence of the devices to legally marketed predicate devices, which is a regulatory pathway for approval, but it does not present a detailed study as you've outlined.
§ 886.5916 Rigid gas permeable contact lens.
(a)
Identification. A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.