Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, and are presbyopic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic or hyperopic and are presbyopic. The lenses may be wom by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 5.00 diopters or less. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients eye and discarded after the recommended wearing period prescribed by the eve care practitioner. The lenses may be disinfected using a chemical disinfection system.

Device Description

Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxy-ethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethylenedlycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as astigmatic (toric) lenses.

Proclear UltraVue/D and Proclear UltraVue/N (omafilcon A) Soft (Hydrophilic) Contact Lenses are available as a multifocal lens with an aspherical front surface and spherical back sufface for the correction of visual acuity in presbyopic persons who are myopic or hyperopic. The Proclear UltraVue/D and Proclear UltraVue/N is designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear UltraVue/D has a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear UltraVue/N has a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. The lens material, omafilcon A is a copolymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphoryicholine crosslinked with ethyleneglycol dimethacrylate. The Proclear UltraVue/D and Proclear UltraVue/N (omafilcon A) Soft (Hydrophilic) Contact Lenses are flexible transparent hemispherical shells.

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are made of polymer of 2-hydroxyethylmethacrylate and 2-methacryloyloxyethyl phosphorylcholine crosslinked with ethyleneglycol dimethacrylate. The lenses are tinted edge for visibility purposes with the color additive C. I. Reactive Blue 4. The front surface of the Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric contact lenses are designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength. The Proclear UltraVue/D 2000T with a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear UltraVue/N 2000T with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision. Both lenses are a flexible transparent hemispherical shell.

AI/ML Overview

This is a 510(k) premarket notification for CooperVision contact lenses (Proclear UltraVue Toric, Proclear UltraVue Multifocal, and Proclear UltraVue 2000T Multifocal Toric). As such, it establishes substantial equivalence to predicate devices rather than conducting new clinical studies with acceptance criteria and statistical analyses as would be found in a PMA submission.

Therefore, the following information regarding acceptance criteria and a study proving a device meets them is not applicable to this document:

A table of acceptance criteria and the reported device performance: Not present in a 510(k). The document provides physical properties of the lenses and compares them to predicate devices in a "Substantial Equivalence Table."
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set as described for a clinical study is detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable; this is not a study assessing diagnostic performance against ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable; this is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable; this is not a machine learning device.
How the ground truth for the training set was established: Not applicable.

What the document does provide in lieu of a typical clinical study:

The document focuses on establishing substantial equivalence to already legally marketed predicate devices. This is achieved by demonstrating that the subject devices have:

Same Material: Omafilcon A.
Similar Physical Properties: Water Content (59%), Light Transmittance (>90%), Index of Refraction (1.40).
Similar Design and Intended Use:
- Proclear UltraVue Toric (Subject Device) is compared to Proclear Tailor Made Toric (Predicate Device K952152) – both are Omafilcon A, Back Surface Toric, and for correction of visual acuity in patients with myopia or hyperopia and astigmatism.
- Proclear UltraVue Multifocal (Subject Device) is compared to Proclear UltraVue Multifocal (Predicate Device K043129) – both are Omafilcon A, Aspheric Multifocal, and for correction of visual acuity in patients with myopia or hyperopia and presbyopia.
- Proclear UltraVue 2000T Multifocal Toric (Subject Device) is compared to Proclear UltraVue 2000T Multifocal Toric (Predicate Device K0423129) – both are Omafilcon A, Aspheric Multifocal Toric, and for correction of visual acuity in patients with myopia or hyperopia, astigmatic, and presbyopic.
Different Manufacturing Method: The subject devices use a "Finished Inside Polymerization System" compared to the "Lathe-Cut" method of the predicate devices. The submission implicitly argues that this manufacturing change does not raise new questions of safety or effectiveness, as evidenced by the similar physical properties and intended use.
Oxygen Permeability: There is a slight difference mentioned (21.05 for Lathed Predicate vs. 25.0 for Finished Inside Polymerization System Subject Device, though the table for "Lathe-Cut Omafilcon A" shows 21.05 and the physical properties lists 21.05 x 10^-9 for the subject device - the table has a discrepancy here). This difference, if acknowledged and explained, is presumably not considered significant enough to negate substantial equivalence.

Conclusion stated in the document:

The conclusion emphasizes that the device will be manufactured according to specified process controls and an established quality assurance program, similar to devices already marketed by CooperVision. It states that "Being similar with respect to indications for use, the risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis." This statement serves as the basis for the declaration of substantial equivalence.

Summary

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Ko5.717

MAY 1 3 2005

CooperVision, Inc.

Scottsville, NY 14546

711 North Road

Bonnie Tsymbal

711 North Road

(585) 264-3210

(585) 889-5688

March 17th, 2005

CooperVision, Inc.

Scottsville, NY 14546

5 E & E C M C C C C C C C C C C

Premarket Notification

Omafilcon A FIP's

A. B. OHIR. A. H. M. H. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M. M.

510(k) SUMMARY

1. Submitter:

Submitted on Behalf of:

트 Company Name:
ಂಗ್ //siona2
t Address:

2. Official Correspondent:

트 Company Name:
트 Address:
보 Phone:
트 Fax:

3. Date Summary Prepared:

Device Identification: 4.

Proclear UltraVue Toric Trade Name: Proclear UltraVue Multifocal Proclear UltraVue 2000T Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact
l Common Name:
. Classification
. Device Classification:

Lenses Hydrophilic Soft Contact Lens Lenses, Soft Contact, Daily Wear 86LPL

Class II (21 CFR 886.5925)

5. Intended Use:

{1}------------------------------------------------

ිරියා විද්ධික් හෝ සිට පසු සිංහ ප්‍රධාන පිහිටා පිහිට පිහිට

6. Device Description

Proclear UltraVue Toric

지 Chord Diameter:
Center Thickness (minus): Center Thickness (plus)
트 Base Curve:
. Spherical Powers:
8 Cylinder Powers:
B Axis

13.6 to 15.2 mm 0.15 mm to 0.20 mm 0.20 mm to 0.96 mm 8.0 mm to 9.3 mm -20.00 D to +20.00 D -0.75 to -5.00 D 1° to 180°

Proclear UltraVue/D Multifocal and Proclear UltraVue/N Multifocal

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Image /page/2/Picture/0 description: The image contains the Chinese characters "人偶用方式", which translates to "doll use method". There is also the character "球", which translates to "ball". The characters are written in a traditional style, and the image appears to be a close-up of a document or label.

Premarket Notification

The lens material, omafilcon A is a copolymer of 2-hydroxy-ethylmethacrylate and 2methacryloyloxyethyl phosphoryicholine crosslinked with ethyleneglycol dimethacrylate. The Proclear UltraVue/D and Proclear UltraVue/N (omafilcon A) Soft (Hydrophilic) Contact Lenses are flexible transparent hemispherical shells of the following dimensions:

的影音的一起,一起一起,一起一起,

Chord Diameter: 트
Center Thickness (minus): l Center Thickness (plus)
. Base Curve:
l Spherical Powers:
Add Powers: 하
Central Zone Diameter:

14.5 mm 0.15 mm to 0.20 mm 0.20 mm to 0.96 mm 8.3 mm to 8.9mm -20.00 D to +20.00 D +1.00 to +4.00 D 2.3 mm to 2.6 mm (Proclear UltraVue/D) 1.7 mm to 2.0 mm (Proclear UltraVue/N)

Proclear UltraVue/D 2000T Multifocal Toric and Proclear UltraVue/N 2000T Multifocal Toric

The front surface of the Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses is aspherical, with the anterior surface having a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric contact lenses are designed with two multifocal zones, as well as the edge shape being optimized to provide comfort without sacrificing tensile strength.

The Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are available in two versions. The Proclear UltraVue/D 2000T with a spherical central zone for the correction of distance vision and an aspherical annular zone for the correction of intermediate and near vision. The Proclear UltraVue/N 2000T with a spherical central zone for the correction of near vision and an aspherical annular zone for the correction of intermediate and distance vision.

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11-12 EN A. R :

Both lenses are a flexible transparent hemispherical shell of the following dimensions:

장 프로그램 - 대전 - 100 - 100

Chord Diameter: .
Center Thickness (minus): 프 Center Thickness (plus)
트 Base Curve:
. Spherical Powers:
I Cylinder Powers:
1 Add Powers:
Central Zone Diameter:

14.5 mm 0.15 mm to 0.20 mm 0.20 mm to 0.96 mm 8.3 mm to 8.9mm -20.00 D to +20.00 D -0.75 to -2.75 D +1.00 to +3.50 2.3 mm to 2.6 mm (Proclear UltraVue/D 2000T) 1.7 mm to 2.0 mm (Proclear UltraVue/N 2000T)

The physical properties of the lenses are:

Refractive Index at 25° C	1.40
Light Transmittance	>90%
Water Content	59 %
Oxygen Permeability*	$21.05 \times 10^{-1}$

*(cm²/sec) (ml O2/ml x mm Hg) at 35°C. as measured by 2017 Permeometer connected to a curved Rehder guard ring polarographic cell.

{4}------------------------------------------------

@operVision�

Premarket Notification

Lathe- Cut Omafilcon A

7. Substantial Equivalence Table:

	Proclear Tailor Made Toric, ProclearUltraVue Multifocal Proclear UltraVue2000T Multifocal Toric	Proclear UltraVue Toric,Proclear UltraVue Multifocal and ProclearUltraVue 2000T Multifocal Toric
	LathedPredicate Device	Finished Inside Polymerization SystemSubject Device
Material	Omafilcon A	Omafilcon A
Water Content	59%	59%
Light
Transmittance	>90%	>90%
Index ofRefraction	1.40	1.40
Oxygen
Permeability	21.05	25.0
	DESIGN COMPARISON
	Proclear UltraVue Toric	Proclear Tailor Made Toric
	Subject Device	Predicate Device K952152
	Omafilcon A	Omafilcon A
Lens Design	Back Surface Toric	Back Surface Toric
Intended Use	Correction of visual acuity in patients with	Correction of visual acuity in patients with
	myopia or hyperopia, and are astigmatic	myopia or hyperopia, and are astigmatic
ProductionMethod	Finished Inside Polymerization System	Lathe-Cut
	Proclear UltraVue Multifocal	Proclear UltraVue Multifocal
	Subject Device	Predicate Device K043129
	Omafilcon A	Omafilcon A
Lens Design	Aspheric Multifocal	Aspheric Multifocal
Intended Use	Correction of visual acuity in patients with	Correction of visual acuity in patients with
	myopia or hyperopia, and are presbyopic	myopia or hyperopia, and are presbyopic
ProductionMethod	Finished Inside Polymerization System	Lathe-Cut
	Proclear UltraVue 2000T Multifocal ToricSubject DeviceOmafilcon A	Proclear UltraVue 2000T Multifocal ToricPredicate Device K0423129Omafilcon A
Lens Design	Aspheric Multifocal Toric	Aspheric Multifocal Toric
Intended Use	Correction of visual acuity in patients with	Correction of visual acuity in patients with
	myopia or hyperopia, and are astigmatic andpresbyopic	myopia or hyperopia, and are astigmatic andpresbyopic
ProductionMethod	Finished Inside Polymerization System	Lathe-Cut

{5}------------------------------------------------

Premarket Notification

8. CONCLUSION:

The device will be manufactured according to specified process controls and an established quality assurance program. The device will undergo the same manufacturing, packaging and sterilization procedures to devices currently marketed by CooperVision, Inc. Scottsville, NY manufacturing facility. Being similar with respect to indications for use, the risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis.

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with three curved lines forming its body and head, and two wavy lines representing its legs or feet.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 2005

Cooper Vision c/o Ms. Bonnie Tsymbal Sr. Manager Regulatory Affairs and Quality Assurance 711 North Road Scottsville, NY 14546

Re: K050717

Trade/Device Name: Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Proclear UltraVue/D and Proclear UltraVue/N Muttifocal (omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Proclear UltraVue Toric (omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 18, 2005 Received: March 24, 2005

Dear Ms. Tsymbal:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovious your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use batted in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1978, the case of the provisions of the Federal Food, Drug, de necs that have been 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, mereloro, manver of the Act include requirements for annual registration, listing of general controls pro resuring 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 If your device is clausified (600 as a votrols. Existing major regulations affecting your device can may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of reacts concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I Dri b issualite over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of ally it cach and 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 CFN Fat 807), adomig (21 OFR Part 820), good if applicable, the electronic forul in the quality by stells (Sections 531-542 of the Act); 21 CFR 1000-1050.

{7}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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

Sincerely yours,

David M. Whipple

Acting 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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Image /page/8/Picture/0 description: The image shows the logo for CooperVision. The logo is in black and white. The text "CooperVision" is written in a stylized font, with the first two "o"s connected by a line underneath. To the right of the text is a black square with a white swirl inside.

Regulatory Affairs 711 North Road Scottsville, NY 14546 (585) 385-6810 Fax: (585) 889-5688

Indication for Use Statement

510(k) Number:

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric Device Name: (omafilcon A) Soft (hydrophilic) Contact Lens Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (hydrophilic) Contact Lens Proclear UltraVue Toric (omafilcon A) Soft (hydrophilic) Contact Lens

Indication for Use:

Proclear UltraVue/D 2000T and Proclear UltraVue/N 2000T Multifocal Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 3.00 diopters or less, portune manyonic. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Proclear UltraVue/D and Proclear UltraVue/N Multifocal (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with nondiseased eyes that are myopic and are presbyopic. The lenses may be worn by persons who exhibit astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during leass wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Proclear UltraVue Toric (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the r rrection of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 5.00 diopters or less. The lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient and should be decided by the eye care practitioner in consultation with their patients. The lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X
(Per 21 CFR Subpart D)

	(Division Sign-Off)Division of Ophthalmic Ear,Nose and Throat Devises
510(k) Number	K050717 AND/OR

Over-The-Counter (Per 21 CFR Subpart C)

Regulation Number and Section

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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.

510(k) SUMMARY

Submitted on Behalf of:

2. Official Correspondent:

3. Date Summary Prepared:

Device Identification: 4.

Lenses Hydrophilic Soft Contact Lens Lenses, Soft Contact, Daily Wear 86LPL

5. Intended Use:

6. Device Description

Proclear UltraVue Toric

Proclear UltraVue/D Multifocal and Proclear UltraVue/N Multifocal

Central Zone Diameter:

Proclear UltraVue/D 2000T Multifocal Toric and Proclear UltraVue/N 2000T Multifocal Toric

The physical properties of the lenses are:

Lathe- Cut Omafilcon A

7. Substantial Equivalence Table:

8. CONCLUSION:

Indication for Use Statement

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

§ 886.5925 Soft (hydrophilic) contact lens.