OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES

K033594 · Contamac, Ltd. · HQD · Mar 19, 2004 · Ophthalmic

Device Facts

• Record ID: K033594
• Device Name: OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES
• Applicant: Contamac, Ltd.
• Product Code: HQD · Ophthalmic
• Decision Date: Mar 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Multifocal Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring bifocal correction. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system. The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. The lens may be disinfected with a chemical disinfection system only. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

Rigid gas permeable (RGP) contact lenses fabricated from fluorosilicone acrylate (roflufocon A-E); lathe-cut design; spherical, aspheric, bifocal, multifocal, or toric geometries. Used by patients for daily wear to correct refractive errors (myopia, hyperopia, astigmatism, presbyopia) or manage keratoconus. Lenses act as refractive medium to focus light on retina. Prescribed by eyecare practitioners; requires chemical disinfection system. Includes UV blocker (2,2-dihydroxy-4,4-dimethoxybenzophenone). Shipped wet or dry; wet-shipped lenses stored in cleaning/disinfecting solution.

Clinical Evidence

Clinical study of 272 eyes (136 patients) evaluated safety (adverse events, slit lamp findings, symptoms, keratometry) and efficacy (refractive changes, visual acuity, comfort, wearing time). 246 eyes completed study. Results demonstrated safety and efficacy equivalent to predicate devices.

Technological Characteristics

Fluorosilicone acrylate methacrylate copolymer; hydrophobic (<1% water content). Lathe-cut fabrication. UV blocker: 2,2-dihydroxy-4,4-dimethoxybenzophenone. Dk values range 26-125 x 10^-11. Available in spherical, aspheric, bifocal, multifocal, toric designs. Chemical disinfection only.

Indications for Use

Indicated for daily wear in aphakic/non-aphakic persons with non-diseased eyes for correction of myopia, hyperopia, astigmatism (up to 10D), presbyopia (bifocal), or keratoconus management. Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Boston ES Multifocal, Daily Wear (K970698)
• Boston XO, Daily Wear (K000795)
• BOSTON XO, EO, ES, 7 RXD, Daily Wear (K002025)
• FluoroPerm 30, 60, 90, 151 (K940277)
• FluoroPerm HDS (P87024-S36)
• ComfortKone, Daily Wear (K990264)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K033594 |
|--------------------------------|---------|
|--------------------------------|---------|

Applicant information:

| Date Prepared: | November 16, 2003 |
|-----------------|----------------------------------------------------------------------|
| Name: | CONTAMAC Ltd. |
| Address | Bearwalden Business Park<br>Saffron Walden<br>Essex England CB11 4JX |
| Contact Person: | Robert McGregor |
| Phone number: | 44-1799 542 000 |
| US Agent: | Medvice Consulting, Inc.<br>Martin Dalsing |
| Phone number | [phone] |
| Fax number | [phone] |

Device Information:

| Device Classification: | Class II |
|------------------------|-------------------------------------------------------------|
| Classification Number: | HQD |
| Classification Name: | Lenses, Rigid Gas Permeable, Daily Wear |
| Trade Name: | OPTIMUM GP (Oxygen Permeable) Daily Wear Contact<br>Lenses. |

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### Equivalent Devices:

The OPTIMUM GP (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon I), & (rollufocon to the following The OPTIMUM GP (follulocoll A), (romatoodl D), (ronaloour of), (ronaloour of the following predicate devices.

| | Predicate devices:<br>Predicate device manufacturer: | Device name: |
|-----|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | Polymer Technology<br>1400 North Goodman Street<br>Rochester, NY 14603 | Boston ES Multifocal, Daily Wear<br>510(k) #: K970698 |
| 2.) | Polymer Technology<br>1400 North Goodman Street<br>Rochester, NY 14603 | Boston XO, Daily Wear<br>510(k) #: K000795 |
| 3.) | Paragon Vision Sciences<br>947 E. Impala Avenue<br>Mewa, AZ 85204 | BOSTON XO, EO, ES, 7 RXD, Daily Wear<br>510(k) #: K002025 (wet shipped lenses)<br>FluoroPerm 30, 510(k) #: K940277<br>FluoroPerm 60, 510(k) #: K940277<br>FluoroPerm 90, 510(k) #: K940277<br>FluoroPerm 151, 510(k) #:K940277<br>FluoroPerm HDS, P87024-S36 |
| 4.) | Metro Optics, Inc.<br>15802 Vision Drive<br>Pflugerville, TX 78660 | ComfortKone, Daily Wear<br>510(k) #: K990264 (Keratoconus Contact Lens Design) |

### Device Description:

The OPTIMUM GP series of contact lenses are fabricated from the hydrophobic contact lens materials (roflufocon A), (roflufocon B), (roflufocon C), (roflufocon D), & (roflufocon E). When place on the (formocon A), (fondiocon DJ, (romatocer en) (1911). "The sess act as a refracting medium to focus light rays upon the retina.

The OPTIMUM GP Contact Lens for Daily Wear are available as lathe cut contact lenses with spherical, aspheric, bifocal, multifocal or toric anterior and/or posterior designs in clear and tinted versions.

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The OPTIMUM GP Contact Lens for Daily Wear is a rigid gas permeable methacrylate copolymer of I he OPT IMUM GF Collact Letts for Dany Women at Methacrylaxypropyl Methyl methacrylate, 1,1,1,3,3,3 - Hexandovosoprops inc. L. 3,3-tectakis(trimethyl siloxy)disiloxane, 2Tris(trimethylsiloxy) silane, 1,3-bis(methacryloxypropy))-1,1,3,3-tec Tris(trimethylslloxy) shalle, 1,3-bls(includer).com/propy.com/props/inked with Ethylene Glycol Dimethacrylate.

Dimethacrylate.
The OPTIMUM GP Contact Lens for Daily Wear incorporates a visibility tint to make the lens more The OPTIMUM GP Contact Lenses contain one or more of the following color additives: D&C Green
visible for handling. The tinted lenses contain one of the following color addit No.6, C.I. Solvent yellow No. 18, and FD&C Red No. 17.

### UV Blocker

O v Blocker
In the OPTIMUM GP Contact Least Collections of All Justhershappenhenene . The JV to block UV radiation. The UV Blocker is 2,2 - Dihydroxy-4,4 "dimethoxybenzophenone. The UV
to block UV radiation. The UV Blocker is 2,2 - Dibydroxy-4,4 "dimethoxy" (21 for to block UV radiation. The UV Blocker is 2,2 -Darydoxy ", Fennances - 1, 1 - 1
blocking for OPTIMUM GP averages > 98% in the UVB range of 280mm - 315mm and 95% in the UVA range of 316 - 380nm.

The physical properties of the OPTIMUM GP Contact Lens are:

| | (roflufocon A) | (roflufocon B) | (roflufocon C) | (roflufocon d) | (roflufocon e) |
|---------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------|--------------------------------------------------------------------|
| Refractive Index | 1.4527 | 1.4454 | 1.4406 | 1.4333 | 1.4332 |
| Light Transmission<br>(clear) | >97% | >97% | >97% | >97% | >97% |
| Light Transmission<br>(tinted) | >90% | >90% | >90% | >90% | >90% |
| Wetting Angle<br>(Dynamic contact<br>receding angle) | 12° | 13° | 6° | 3° | 6° |
| Specific Gravity | 1.189 | 1.181 | 1.178 | 1.166 | 1.155 |
| Oxygen<br>Permeability (Dk)<br>ISO/FATT Method | $26 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $46 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $65 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) | $100 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml<br>x mm Hg @ 35°C) | $125 x 10^{-11}$<br>(cm²/sec) (ml O₂/ml x<br>mm Hg @ 35°C) |
| Visitint lenses<br>contain one or more<br>of the following<br>color additives and<br>conform to:<br>21 CFR Part 73 &<br>74, Subpart D | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 | D & C Green<br>No. 6, FD & C<br>Red No. 17 CI<br>Solvent Yellow<br>18 | D & C Green No.<br>6, FD & C Red<br>No. 17 CI Solvent<br>Yellow 18 |

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### Intended Uses:

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, roflufocon D, and rother competition I he OPT I MUM GF (fonulocon A, ronaloon D, ronis is indicated for daily wear for the correction of Spherical Rigid Cas Femicable (NOF) Connect roll it in in-diseased eyes with myopia of hyperopia. The lens may be disinfected with a chemical disinfection system only.

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual 1 orie Rigid Gas Penneable (KOT) Condict Dons is insectives with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and rother man the the The OF I Invitified Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the Munitional Mitocal Night Oas I cimically (1627) okic persons with non-diseased eyes with myopia or correction of visual actiry in apliatio and now tipm not exceeding 4 diopters and are presbyopic requiring liyferopia antivor possesses retraorre antegramar be disinfected with a chemical disinfection system only.

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon D, and roflufocon D, and roflufocon E) The OF TIMOM Of (Romatooon 14, romalovon act Lens is indicated for daily wear for promoted by atten Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the Correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons. The lens may be disinfected with a chemical disinfection system only.

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### Description of Safety:

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the OPTIMUM GP Rigid Gas Permeable Contact Lens material. The results of all testing demonstrated that Of TIMOM Of Trigit Ous I entreaste Coanable Contact Lens is equivalent Lens is equivalent to the the surely marketed predicate devices previously identified. A summary of these results from the preclinical studies is presented below.

### Toxicology:

In-Vitro Cytotoxicity: ISO 10993-5 was conducted in accordance with standards on test article. The test article meets the requirements of the Agarose Overlay Method.

Systemic Toxicity: The lens material meets the requirements of the systemic injection test and is considered non-toxic.

Acute Ocular Irritation: Acute ocular irritation test was performed and produced no ocular irritation.

### Packaging

The primary container for shipping the OPTIMUM GP Rigid Gas Permeable Contact Lenses is the Alcon Contact Lens Case, with clearance under 510(k) K974281. The lens is shipped (wet) non-sterile in the OPTIMUM by Lobob Cleaning and Disinfecting Storage solution, with clearance under 510(k) 014162. The solution contains lauryl sulfate salt of imidazoline, octylphenoxy polyethoxyethanol and preserved with benzyl alcohol.

### Shelf Life

The OPTIMUM GP Rigid Gas Permeable lens is a hydrophobic contact lens material with <1% water content. When the OPTIMUM GP lenses are shipped dry, shelf life studies are not required for clearance of this material.

When the OPTIMUM GP lenses are shipped wet, shelf life studies are required for clearance of this material. See following Bioburden Testing to Evaluate 30 -Day Storage (Shelf Life) in a Cleaning, Disinfecting and Storage GP Solution:

Contamac performed stability, compatibility and microbiology testing on OPTIMUM GP Contact Lenses wet shipped in OPTIMUM by Lobob GP Cleaning, Disinfecting and Storage Solution and stored for up to 30 days. This testing combined with utilization of the contact lens container identified supports the claim of substantial equivalence to Boston RGP lenses wet shipped and stored for up to 30 days.

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Stability/Compatibility ~ The Fluorosilicone acrylate OPTIMUM GP Rigid Gas Permeable Contact Lenses were subjected to a thirty-day soak in OPTIMUM by Lobob GP Cleaning, Disinfecting and Lensts were subjected to a the lens compatibility protocol. The average changes for each parameter (diameter, base curve and power), relative to the initial measurements were determined. (thanceer, base our o ma porter), reases at room temperature for thirty days the OPTIMUM GP rigid gas permeable contact lenses were determined to be physically compatible with OPTIMUM by Lobob GP solutions.

Microbiology ~ A bioburden study was completed. A set of test lenses was cleaned with OPTIMUM by Lobob Extra Strength Cleaner for rigid gas permeable lenses and subjected to bioburden testing. In this Looo Extra Successive Included the storage in OPTIMUM by Lobob GP Cleaning, Disinfecting and ttos, tenses were to vanued that the colony forming units (CFU) per lens was less than 2. The acceptance criteria is 100 CFU per lens.

### Solution Compatibility

Studies were conducted on blue tinted lens material. Lenses were run through 30 cycles of cleaning and conditioning to establish the compatibility of the lens material with the recommended care regimen. The parameters of the base curve, back vertex power, total diameter and overall lens physical appearance were pannievers of the oal ver re, resultive of 30 cycles. Initial and final data were compared. There were no significant changes to lens parameters after 30 complete cycles.

### Clinical Testing

Below is a summary of the clinical study carried out to evaluate the safety and efficacy of the OPTIMUM GP Rigid Gas Permeable Contact Lens material when used as a daily wear contact lens for the correction of visual acuity.

A total of 272 eyes (136 patients) were entered into the study by 10 investigators. Prior to entry into this study each patient was required to read and sign a statement of informed consent. All patients who signed a Statement of Informed Consent are accounted for in this report. Of the 272 eyes (136 patients enrolled), 246 eyes (123 patients) completed the study.

The safety and efficacy measures for the study were:

Safety: Adverse Events, Positive Slit Lamp Findings, Symptoms/Complaints and Keratometry Changes.

Efficacy: Refractive Changes, Lens Visual Acuity, Lens VA Line Changes, Comfort and Vision, Average Wearing time.

The sponsor concludes that OPTIMUM Rigid Gas Permeable Contact Lens material is equivalent in safety and efficacy to the predicate devices.

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### Substantial Equivalence:

The OPTIMUM GP Rigid Gas Permeable Contact Lens is substantially equivalent and does not raise The OPT IMUM GP Rigit Oas I cincation Cothace Dollars Jose Manager In and Subscribed previously. The difference between the devices is the USAN name.

The following comparison table depicts characteristics of the OPTIMUM GP material, as well as the predicate devices.

| | Characteristics<br>Comparison | OPTIMUM GP | BOSTON ES, XO | FLUOROPERM<br>30, 60, 90, 151, HDS |
|-----|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | New Device | Predicate Device | Predicate Device |
| 1.) | Functionality | After machining from the<br>optical blank, the contact<br>lenses act as a refractive<br>medium that focus light rays<br>from near and distant objects<br>on the retina. | After machining from the<br>optical blank, the contact<br>lenses act as a refractive<br>medium that focus light<br>rays from near and distant<br>objects on the retina. | After machining from the<br>optical blank, the contact<br>lenses act as a refractive<br>medium that focus light<br>rays from near and distant<br>objects on the retina. |
| 2.) | Indication for Use | Daily wear, Rigid Gas<br>Permeable RGP Contact<br>Lens | Daily wear, Rigid Gas<br>Permeable RGP Contact<br>Lens | Daily wear, Rigid Gas<br>Permeable RGP Contact<br>Lens |
| 3.) | Production<br>Method | Lathe-cut | Lathe-cut | Lathe-cut |
| 4.) | FDA Group # | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate |
| 5.) | USAN name | roflufocon A, B, C, D, E | enflufocon A, B | paflufocon A, B, C, D |
| 6.) | Water Content | <1% | <1% | <1% |
| 7.) | UV<br>Absorber/Blocker<br>available | YES | YES | YES |

### Substantial Equivalence table

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Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

MAR 1 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CONTAMAC Ltd. c/o Martin Dalsing Medvice Consulting, Inc. 623 Glacier Dr. Grand Junction, CO 81503

Re: K033594

Trade/Device Name: OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D and roflufocon E) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid gas permeable contact lens. Regulatory Class: Class II Product Code: HOD Dated: February 23, 2004 Received: February 24, 2004

Dear Mr. Dalsing:

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.

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.

{8}------------------------------------------------

### Page 2 - Martin Dalsing

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses. Device Name:

### INDICATIONS FOR USE:

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) The OF TINCH OF (ROP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
`X`
or
Over-The-Counter Use **__**

(Optional Format 1-2-96)

*Daniel W. Brown, Ph.D.*
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number K033594

{10}------------------------------------------------

#### OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses. Device Name:

### INDICATIONS FOR USE:

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) Toric Rigid Gas Permeable (RGP) Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10.00 diopters. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the

lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

**Prescription Use** X
(Per 21 CFR 801.109)

or

Over-The-Counter Use

(Optional Format 1-2-96)

Karen Warburton

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

510(k) Number_KO33594

{11}------------------------------------------------

#### OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses. Device Name:

### INDICATIONS FOR USE:

::

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) I the OF THUSA OF (rollaboren meable (RGP) Contact Lens is indicated for daily wear for the Mithmocal Divisual regio Ous Fermedic (1127) okic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring ifypeopla antwor possesses renear o actess may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109)

OL

Over-The-Counter Use

(Optional Format 1-2-96)

Karen Warburton

(Division Sign-Off) Division of Ophthalmic Ear. Nose and Throat Devises

510(k) Number K033594

100

{12}------------------------------------------------

### OPTIMUM GP (Oxygen Permeable) Daily Wear Contact Lenses. Device Name:

### INDICATIONS FOR USE:

The OPTIMUM GP (roflufocon A, roflufocon B, roflufocon C, roflufocon D, and roflufocon E) The Of TIMON Of ((tommocoll 1, rendocour and Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes. The lens may also be prescribed for the ItCraction of refractive ametropia, hyperopia, hyperopia and astigmatism) in aphakic and not aphakic persons. The lens may be disinfected with a chemical disinfection system only.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ✗
or
Over-The-Counter Use __
(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Kmer Warbutor
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number 033594