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

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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® 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 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® 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 {2}------------------------------------------------ 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. 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 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™ 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. {3}------------------------------------------------ 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. 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 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 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. 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. Predicate Device Classification Name: rigid gas permeable contact lenses (hydrophobic) Proprietary Name: {4}------------------------------------------------ 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: 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. {5}------------------------------------------------ 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. {6}------------------------------------------------ ### 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 {7}------------------------------------------------ #### 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 {8}------------------------------------------------ #### 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 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 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 OR 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_ {9}------------------------------------------------ #### 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 OR 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. {10}------------------------------------------------ #### 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. 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 eves. Prescription Use _____________X OR 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 3 {11}------------------------------------------------ #### 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. 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 eves. Prescription Use OR Over-The-Counter Use 4 ### (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. {12}------------------------------------------------ 5 # 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. 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. Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR 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 {13}------------------------------------------------ б # 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. 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. Prescription Use X OR 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. {14}------------------------------------------------ #### 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. 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. Prescription Use OR Over-The-Counter Use 7 ## (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