K Number

Device Name

FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES

Manufacturer

PARAGON VISION SCIENCES

Date Cleared

2006-02-10

(109 days)

Product Code

HQD HOD

Regulation Number

886.5916

Intended Use

FluoroPerm® 92 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. FluoroPerm® 92 rigid gas permicable bifocal, or toric 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. FluoroPerm® 92 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 ad power. FluoroPerm® 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. 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 +4.00 D add power. 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 eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. Paragon HDS® 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 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. FluoroPerm® 30 rigid gas permeable contact lenses 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 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 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 to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. 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. 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. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 151 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 to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. F FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power. 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 spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiscased 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 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. 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.

Device Description

Keratoconus contact lens designs 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; paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60, Paragon HDS®), paflufocon C (FluoroPerm® 30, Paragon Thin""), and paflufocon D (FluoroPerm® 151. Paragon HDS® 100). These materials are thermoset copolymers derived from fluorosilicone acrylate monomers. The lenses may be tinted to offer a handling aid 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. These products may be plasma treated. 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 four spherical or aspherical curves progressively flatter than the base curve.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes rigid gas permeable contact lenses and their materials, indications, and manufacturing process. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.

Therapeutic

Yes.
The device is indicated for "keratoconus management," which is a treatment for a disease, making it a therapeutic device.

Diagnostic

Explanation: The device is a contact lens indicated for the correction of visual acuity; it does not diagnose medical conditions.

SaMD (Software as a Medical Device)

The device description clearly states that the device is a physical contact lens made from specific materials and manufactured using lath cut techniques. It also mentions physical characteristics like tinting and UV absorbers. This indicates a hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description and Intended Use: The text clearly describes the device as rigid gas permeable contact lenses. Their intended use is for the correction of visual acuity in individuals with various refractive errors (nearsightedness, farsightedness, astigmatism, presbyopia) and for keratoconus management.
Lack of Biological Sample Analysis: There is no mention of the device being used to analyze any biological samples from the patient. The device is placed directly on the eye for vision correction.

Therefore, the device described is a medical device for vision correction, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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. FluoroPerm® 92 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 ad power.

FluoroPerm® 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. 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 +4.00 D add power.

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 eye care practitioner. Paragon HDS® rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

Paragon HDS® 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 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.

FluoroPerm® 30 rigid gas permeable contact lenses 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 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 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 to 4.00 diopters that does not interfere with visual acuity. Paragon Thin" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. 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.

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. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 151 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 to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

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 spherical, aspheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiscased 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 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. 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.

Product codes (comma separated list FDA assigned to the subject device)

HOD

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eyes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

eye care practitioner

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Boston® II (itafocon A) rigid gas permeable contact lens approved in PMA P820065.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

FEB 1 0 2006

K052983

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

FluoroPerm® 30 and Paragon Thin" (paflufocon C); FluoroPerm® 60 and Paragon HDS® (paflufocon B); FluoroPerm® 92 (patufocon A); and, FluoroPerm® 151 and Paragon HDS® 100 (paflufocon D) RGP Contact Lenses for Daily Wear Keratoconus Indication

Date of Submission

January 31, 2006

Submitter

Company Name: Address: Phone: Fax:

Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-892-7602 480-892-3226

Manufacturer Information

Company Name: Address: Phone: Fax:

Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-892-7602 480-892-3226

Official Correspondent

Name: Address: Address: Phone: Fax:

William E. Meyers, Ph.D. % Paragon Vision Sciences 945 East Impala Ave., Mesa, AZ 85204 480-507-7606 480-892-3226

Device Identification

Common Name: Trade Name:

Classification:

Predicate Device

Contact lens FluoroPerm® 30, FluoroPerm® 60, FluoroPerm® 92, FluoroPerm® 151, Paragon Thin", Paragon HDS and Paragon HDS 100 21 CFR 886.5916; rigid gas permeable contact lens, Class II - daily wear contact lens

A claim of substantial equivalence to the Boston® II (itafocon A) rigid gas permeable contact lens in keratoconus lens designs approved in PMA P820065. on 11/17/1983

Device Description

The lenses may be tinted to offer a handling aid 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. These products may be plasma treated.

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 four spherical or aspherical curves progressively flatter than the base curve.

Properties of the Contact Lenses

	FluoroPerm					Paragon
Property	30	60	92	151	Thin	HDS	HDS 100
Specific Gravity	1.14	1.15	1.10	1.10	1.145	1.16	1.10
Refractive Index	1.466	1.453	1.453	1.442	1.463	1.449	1.442
% Light
Transmittance*	94	95	93	93	94	95	93
% Water Content	145

*Blue tinted material

**Revised Method of I. Fatt

Safety and Efficacy

The safety and efficacy of paflufocon A (FluoroPerm® 92), paflufocon B (FluoroPerm® 60 and Paragon HDS®), paflufocon C (FluoroPerm® 30 and Paragon Thin") and paflufocon D (FluoroPerm® 151 and Paragon HDS® 100) materials as rigid gas permeable contact lenses have been demonstrated in PMA P870024 and various of its supplements.

Intended Use

Device Name: FluoroPerm® 30 (paflufocon C) rigid gas permeable contact lenses

FluoroPerm® 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 that are nearsighted (myopic), farsighted (hyperopic), and may exhibit corneal 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 eves. 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 (paflufocon C) rigid gas permeable contact lenses Device Name:

Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin" rigid gas permeable spheric and bifocal contact tenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eves 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" contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes. Paragon Thin" toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. Paragon Thin" bifocal lenses are indicated to treat presbvopia up to +4.00 D add power.

FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses Device Name:

FluoroPerm® 60 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 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 +4.00 D add power.

Paragon HDS (paflufocon B) rigid gas permeable contact lenses Device Name:

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 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® 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.

Device Name:

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. 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-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® 92 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® 151 (paflufocon D) rigid gas permeable contact lenses Device Name:

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. FluoroPerm® 151 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 151 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 to 4.00 diopters that does not interfere with visual acuity. FluoroPerm® 151 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eyes, daily wear application only. F FluoroPerm® 151 toric contact lenses are indicated to correct astigmatism of up to 6.00 diopters. FluoroPerm® 151 bifocal lenses are indicated to treat presbyopia up to +4.00 D add power.

Paragon HDS® 100 (paflufocon D) rigid gas permeable contact lenses Device Name:

Paragon HDS® 100 rigid gas permeable spheric and bifocal contact lenses are indicated for the correction of visual acuity in not-aphakic persons with nondiseased eves 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 contact lenses are indicated for persons requiring keratoconus management with otherwise non-diseased eves, daily wear application only. 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.

Substantial Equivalence

The FluoroPerm® 30 and Paragon Thin" (paflufocon C); FluoroPerm® 60 and Paragon HDS® (paflufocon B); FluoroPerm® 92 (paflufocon A); and, FluoroPerm® 151 and Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contact Lenses are similar to the currently marketed Boston® II (itafocon A) Rigid Gas Permeable Contact Lens, in that all fall into the same FDA contact lens classification (Class II) and all are manufactured by the same manufacturing process. The following Substantial Equivalence Summary Table lists the similarities and differences among the devices.

| Similarities | | FluoroPerm® | | | | Paragon
Thin™ | Paragon
HDS® | Paragon
HDS® 100 |
|----------------------------------|---------------|---------------|---------------|---------------|---------------|------------------|-----------------|---------------------|
| | Boston® II | 30 | 60 | 92 | 151 | Daily Wear | Daily Wear | Daily Wear |
| Indications
for Use | Daily
Wear | Daily
Wear | Daily
Wear | Daily
Wear | Daily
Wear | | | |
| Differences | | paflufocon | | | | | | |
| Material | itafocon | C | B | A | D | C | B | D |
| Indication
for
Keratoconus | YES | NO | NO | NO | NO | NO | NO | NO |

Substantial Equivalence Summary Table

As the comparison table shows there are virtually no differences between the products offered by Paragon Vision Sciences and the Boston® II product, except material and the indication for keratoconus.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2006

Paragon Vision Sciences c/o William E. Meyers, PhD Vice President, Science and Technology 947 East Impala Ave. Mesa, AZ 85204-6619

Re: K052983

Trade/Device Name: FluoroPerm® 92 (paflufocon A) Rigid Gas Permeable Contact Lenses FluoroPerm® 60 (paflufocon B) Rigid Gas Permeable Contact Lenses Paragon HDS® (paflufocon B) Rigid Gas Permeable Contact Lenses FluoroPerm® 30 (paflufocon C) Rigid Gas Permeable Contact Lenses Paragon Thin™ (paflufocon C) Rigid Gas Permeable Contact I enses FluoroPerm® 151 (paflufocon D) Rigid Gas Permeable Contact ' enses Paragon HDS® 100 (paflufocon D) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD Dated: January 13, 2006 Received: January 17, 2006

Dear Dr. Meyers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Page 2 - William Meyers, PhD

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M B Eycholtz, mD

Malvina B. Eydelman, M.D. Acting Division Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications For Use

510(k) Number (if known): K052983

Device Name:

FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses Paragon HDS® (paflufocon B) rigid gas permeable contact lenses FluoroPerm® 30 (paflufocon C) rigid gas permeable contact lenses Paragon Thin" (paflufocon C) rigid gas permeable contact lenses FluoroPerm® 151 (paflufocon D) rigid gas permeable contact lenses Paragon HDS® 100 (paflufocon D) rigid gas permeable contact lenses

Indications For Use:

FluoroPerm® 92

FluoroPerm® 60

J. Savita

vision of Ophthalmic Ea Nose and Throat Devises

510(k) Number

Page 1 of 3

Paragon HDS®

FluoroPerm® 30

FluoroPerm® 30 rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

Paragon Thin™

Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner.

FluoroPerm® 151

Savirata

510(k) Number

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FluoroPerm® 151 (continued)

Paragon HDS® 100

Prescription Use X
(Part 21 CFR 801 Subpart D)

AND/OR

Over – the – Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODF)
--------------------------------------------------------	--

Myna Smith

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices

Page 3 of 3

510(k) Number K052453