K Number

Device Name

FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN

Manufacturer

PARAGON VISION SCIENCES

Date Cleared

2012-06-28

(87 days)

Product Code

HQD

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 permeable 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 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. 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. In daily wear use only. FluoroPerm® 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. FluoroPerm® 60 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® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only. FluoroPerm® 60 rigid gas permeable spheric 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 dionters that does not interfere with visual acuity. 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. In daily wear use only. FluoroPerm® 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 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 non-diseased 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® 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. 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 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. 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. In daily wear use only, FluoroPerm® 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 spheric 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. FluoroPerm® 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. 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 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. 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. In daily wear use only, 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 non-diseased 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 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.

Device Description

FluoroPerm® 92, FluoroPerm® 60, Paragon HDS®, FluoroPerm® 30, Paragon Thin™, and FluoroPerm® 151, and Paragon HDS® 100 lenses are available as lathe cut rigid gas permeable contact lenses for daily wear only. The lenses are manufactured from these FDA approved contact lens materials; patlufocon A (FluoroPerm®92), patlufocon 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 lenses may be available with an ultraviolet absorber (not in all colors and materials). The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve. FluoroPerm® 92, FluoroPerm® 60, FluoroPerm® 151, Paragon HDS®, and 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. FluoroPerm® 92. FluoroPerm® 60, FluoroPerm® 151, Paragon HDS® 100 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only. FluoroPerm® 30 and Paragon Thin" rigid gas permeable contact lenses are indicated for daily wear as recommended by the eye care practitioner. The 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. . The safety and effectiveness of paflufocon A (FluoroPerm® 92), patlufocon 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 several of its supplements.

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

K053124, K071266, K070637

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes rigid gas permeable contact lenses and their materials and indications for use. 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 the "management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery". These are all medical conditions or post-surgical states that the device is intended to treat or manage, fulfilling the definition of a therapeutic device.

Diagnostic

No.
The device explicitly states its indication is for the correction of visual acuity and management of irregular corneal conditions, such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty, radial keratotomy, or LASIK surgery. It treats these conditions or aids vision, rather than identifying or diagnosing them.

SaMD (Software as a Medical Device)

The device description clearly states that the devices are "lathe cut rigid gas permeable contact lenses," which are physical hardware devices. There is no mention of software as the primary component or function.

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 Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
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 and the management of irregular corneal conditions. These are physical devices applied to the eye, not used to analyze biological specimens.

The information provided aligns with the description of a medical device used for vision correction and corneal management, not an in vitro diagnostic test.

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 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. 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.

In daily wear use only. FluoroPerm® 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.

FluoroPerm® 60 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® 60 rigid gas permeable bifocal, or toric contact lenses are indicated for daily wear only.

FluoroPerm® 60 rigid gas permeable spheric 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 dionters that does not interfere with visual acuity. 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.

In daily wear use only. FluoroPerm® 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 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 non-diseased 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® 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.

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 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. 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.

In daily wear use only, FluoroPerm® 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 spheric 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.

FluoroPerm® 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. 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 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. 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.

In daily wear use only, 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 non-diseased eyes.

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.

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

86 HQD

Device Description

The lenses may be tinted to offer a handling aid for locating the lens. The lenses may be available with an ultraviolet absorber (not in all colors and materials).

The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve.

FluoroPerm® 92, FluoroPerm® 60, FluoroPerm® 151, Paragon HDS®, and 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. FluoroPerm® 92. FluoroPerm® 60, FluoroPerm® 151, Paragon HDS® 100 rigid gas permeable bifocal or toric contact lenses are indicated for daily wear only.

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

The 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. .

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Eyes, corneal

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Eye care practitioner, for prescription use.

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)

The safety and effectiveness of paflufocon A (FluoroPerm® 92), patlufocon 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 several of its supplements.

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.

K053124, K071266, K070637

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

Image /page/0/Picture/0 description: The image shows the logo for Paragon Vision Sciences. The logo features the company name in a bold, serif font, with "PARAGON" stacked above "VISION SCIENCES". An abstract, curved design resembling an orbit or eye shape surrounds the text. Below the logo, the tagline "Just watch us" is written in a smaller, sans-serif font.

510(k) Summary

June 28, 2012

Submitter

Company Name:
Address:
Phone:
Fax:
Registration:
Registration:

Official Correspondent

Name: Address: Address: Phone: Fax:

Device Name

Trade & USAN Name:

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

Classification & Ophthalmic Device Branch

Common Name:	Contact lens
Product Code:	86 HQD
Classification Name:	Rigid gas permeable contact lens for daily wear
Classification Panel:	Ophthalmic
Reference:	21 CFR 886.5916; rigid gas permeable
	Contact lens, Class II – daily wear contact lens

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 JUN 2 8 2012 .

K120996

Paragon Vision Sciences, Inc. 945 East Impala Ave., Mesa, AZ 85204 480-892-7602 480-892-3226 Owner Operator # 9024618 Site Registration # 2020433

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

Image /page/1/Picture/1 description: The image shows the logo for Paragon Vision Sciences. The logo has the word "PARAGON" on the top line and "VISION SCIENCES" on the second line. The two lines of text are surrounded by a curved line above and below. The tagline "Just watch us" is below the logo.

FluoroPerm® 92

FluoroPerm® 60

Paragon HDS®

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

Image /page/2/Picture/1 description: The image shows the logo for Paragon Vision Sciences. The logo features the word "PARAGON" in large, bold, sans-serif font, with the words "VISION SCIENCES" in a smaller font size underneath. An oval shape surrounds the text, adding a visual element to the logo. The overall design is clean and professional, conveying a sense of expertise and innovation.

Just watch us

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

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.

Image /page/3/Picture/1 description: The image shows the logo for Paragon Vision Sciences. The word "PARAGON" is in large, bold letters above the words "VISION SCIENCES" in a smaller font. A curved line goes over the word "PARAGON" and under the words "VISION SCIENCES." The phrase "Just watch us" is at the bottom of the image.

FluoroPerm® 151

Paragon HDS® 100

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 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.

Predicate Device Classification Name: rigid gas permeable contact lenses (hydrophobic)

Proprietary Name:

Image /page/4/Picture/1 description: The image shows the logo for Paragon Vision Sciences. The logo consists of the word "PARAGON" in large, bold, sans-serif font above the words "VISION SCIENCES" in a smaller, sans-serif font. An abstract design resembling an incomplete oval surrounds the text, with the top portion of the oval above the word "PARAGON" and the bottom portion below the words "VISION SCIENCES".

Just watch us®

Boston XO (hexafocon A) K053124 Boston EO (enflufocon B) K053124 K053124 Boston ES (enflufocon A) Boston XO2 (hexafocon B) K071266 FluoroPerm® 92 (paflufocon A) K070637 FluoroPerm® 60 & Paragon HDS® (paflufocon B) K070637 FluoroPerm® 30 & Paragon Thin™ (paflufocon C) K070637 FluoroPerm® 151 & Paragon HDS® 100 (paflufocon D) K070637

Date: Jan. 30, 2006 Date: Jan. 30, 2006 Date: Jan. 30, 2006 Date: Aug. 15, 2007 Date: May 1, 2007 Date: May 1, 2007 Date: May 1, 2007 Date: May 1, 2007

Device Description:

The lenses may be tinted to offer a handling aid for locating the lens. The lenses may be available with an ultraviolet absorber (not in all colors and materials).

The lens designs have a posterior surface consisting of a base curve and a series of up to four annular spherical or aspheric curves peripheral to the base curve.

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

Image /page/5/Picture/1 description: The image shows the logo for Paragon Vision Sciences. The logo features the word "PARAGON" in large, bold, serif font above the words "VISION SCIENCES" in a smaller, sans-serif font. Above and below the text is a curved line that frames the text. Below the logo is the text "Just watch us®".

The properties 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 are unchanged, a wide range of larger diameter lenses are now in the market made with lens materials of similar properties such as the predicate materials (Boston XO2 (K071266), Boston XO, Boston EO, and Boston ES (K053124)). Boston XO2 (K071266) has a chord diameter scleral range up to 25.0 mm whereas the FluoroPerm and HDS Families' chord diameters were approved years ago with a chord diameter up to 16.0 mm which limits the use of the scleral lens range. The FluoroPerm and HDS Families' expanded the chord diameter range to include scleral lenses up to 25.0 mm, comparable to the predicate Boston XO2. Our labeling includes fitting instructions appropriate for such larger diameter lenses within the scleral (15.0-25.0 mm) range.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Paragon Vision Sciences, Inc. c/o William E. Meyers, Ph.D. Vice President of Science & Technology 947 East Impala Avenue Mesa, AZ 85204

JUN 2 8 2012

Re: K120996

Trade/Device Name:

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 (RGP) Contact Lenses for Daily Wear

Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens Regulatory Class: Class II Product Code: HQD Dated: March 22, 2012 Received: April 2, 2012

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 for association 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 r ou may , arovisions of the Act include requirements for annual registration, listing of gencial controls proving practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r louse be devices and i Drimination that your device complies with other requirements of the Act

Page 2 - Dr. William Meyers

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Kesia Alexander

Malvina B. Evdelman. M.D. Director

Division of Ophthalmic. Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

510(k) Number K120996:

Device Name: FluoroPerm® 92 (paflufocon A) rigid gas permeable contact lenses

Indications for Use:

FluoroPerm® 92

FluoroPerm® 92 rigid gas permeable spheric 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. 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.

In daily wear use only, FluoroPerm® 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 eves.

Prescription Use

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hampton for Krawczyk

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

K120996 510(k) Number_

510(k) Number K120996:

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

Indications for Use:

FluoroPerm® 60

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 spheric 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. 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.

In daily wear use only, FluoroPerm® 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.

Prescription Use

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

· Concurrence of CDRH, Office of Device Evaluation (ODE)

Hampton for Krawczyk

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

K-120994 510(k) Number.

510(k) Number K120996:

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

Indications for Use:

Paragon HDS®

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.

Prescription Use _____________X

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hampton for Krawczyk

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

K120996
510(k) Number

510(k) Number K120996:

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

Indications for Use:

FluoroPerm® 30

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

Prescription Use

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hampton for Krawczyk

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

K120996 510(k) Number.

Indications for Use

510(k) Number K120996:

Paragon Thin" (paflufocon C) rigid gas permeable contact lenses Device Name:

Indications for Use:

Paragon Thin™

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 100 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hampton for Kwarczyk

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

K120996
510(k) Number

Indications for Use

510(k) Number K120996:

Device Name: FluoroPerm® 151 (paflufocon D) rigid gas permeable contact lenses

Indications for Use:

FluoroPerm® 151

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.

Prescription Use

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hampton for Krawczyk

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

12120996 510(k) Number.

510(k) Number K120996:

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

Indications for Use:

Paragon HDS® 100

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.

Prescription Use

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hampton for Krawczyk
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K120996 510(k) Number