The EYEREVE (hioxifilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The EYEREVE (hioxifilcon D) Toric Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed for daily disposable wear the lens is to be discarded after each removal.

Device Description

The EYEREVE Soft Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material (hioxifilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and 2,3- Dihydroxypropyl Methacrylate (Glycerol Methacrylate), cross-linked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 46% hioxifilcon D and 54% water by weight when immersed in saline solution. The hioxifilcon D name has been adopted by the United States Adopted Names Council (USAN).

A UV absorbing monomer-2-[3-(2H-Benzotriazol-2-yl)-4-hydroxypheny]|ethyl methacrylate-is incorporated in the EYEREVE contact lens material to block UV radiation. The UV blocking characteristics of the lens are as follows:

o >95% in the UVB range of 280nm 315nm
o >67% in the UVA range of 316nm 380mm.

EYEREVE Soft Contact Lenses are available clear or tinted to enhance or alter the apparent color of the eye. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives:

Titanium Dioxide 21 CFR § 73.3126
Phthalocyanine Green 21 CFR § 73.3124
Carbazole Violet 21 CFR § 73.3107
Reactive Blue 19 21 CFR § 73.3127
C.I. Reactive black 5 21 CFR § 73.3127

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive in the center of the contact lens (between layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a standard Clear Pupil diameter of 6.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon D) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:

Refractive Index 1.40 (hydrated)
Light Transmission greater than 98%
Light Transmission (tinted) greater than 96% (at region corresponding to pupil); Opaque or 0-10% (at region corresponding to iris)
Water Content 54 % ± 2%
Oxygen Permeability 21.50 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C)

The EYEREVE soft contact lenses will be manufactured in the sphere and toric design configurations with the following features and properties:

Chord Diameter: 12.80 mm to 15.00 mm
Center Thickness: 0.050 mm to 0.210 mm
Base Curve: 8.0 mm to 9.8 mm
Power Range

Sphere Power: -20.00D to +20.00D in 0.25D steps
Cylinder Power (toric): -0.25D to -4.00D in 0.25D steps
Cylinder Axis (toric): 10° to 180° in 10° steps

AI/ML Overview

The provided document is a 510(k) premarket notification for the EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear. This document describes the device and its substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in a clinical trial. Therefore, the information requested regarding a study with a test set, ground truth, expert adjudication, and MRMC effectiveness is not present in this submission, as these types of studies are typically for diagnostic or screening devices evaluated with AI algorithms.

However, the document does contain information about pre-clinical performance and physicochemical & mechanical properties, which serve as the acceptance criteria for the contact lens material's safety and fundamental characteristics.

Here’s a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is demonstrated through a comparison with predicate devices and compliance with established standards. The acceptance criteria are implied by the ranges and properties shown in the tables and the successful completion of toxicology tests.

Characteristic	Acceptance Criteria (Implied by Predicate & Standards)	EYEREVE Performance
Intended Use	Correction of refractive error for daily wear.	Indicated for daily wear for correction of refractive error in aphakic/non-aphakic persons with non-diseased eyes with myopia or hyperopia. Also for refractive astigmatism <= 0.75D (spherical) or <= 5.00D (toric).
Functionality	Acts as a refractive medium to focus light on retina.	Act as a refractive medium that focus light rays from near and distant objects on the retina.
Indications	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Production Method	Fully molded	Fully molded
USAN name	hioxifilcon D	hioxifilcon D
Water Content (%)	54% ± 2% (for Hioxifilcon D predicates)	54% ± 2%
Oxygen Permeability	Comparable to predicate devices (Hioxifilcon D)	21.50 x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method)
FDA Group	FDA Group 2 (>50% H₂O, non-ionic polymer)	FDA Group 2 (>50% H₂O, non-ionic polymer)
Refractive Index (hydrated)	1.40-1.41 (for Hioxifilcon D predicates)	1.40
UV Blocker	Yes/No (depending on predicate)	Yes (>95% UVB, >67% UVA)
Light Transmission (Visible)	Greater than 98% (clear), 0-10% (iris region tinted)	Greater than 98% (clear), Greater than 96% (pupil region tinted), Opaque or 0-10% (iris region tinted)
Tensile Strength	Demonstrated to be consistent	(Not explicitly given, but stated to be consistent)
Modulus	Demonstrated to be consistent	(Not explicitly given, but stated to be consistent)
% Elongation to break	Demonstrated to be consistent	(Not explicitly given, but stated to be consistent)
Specific Gravity	Demonstrated to be consistent	(Not explicitly given, but stated to be consistent)
Polymerization residuals	Demonstrated to be consistent	(Not explicitly given, but stated to be consistent)
In-Vitro Cytotoxicity	Non-toxic (according to ISO 10993-5)	Non-toxic
Systemic Toxicity	Non-toxic (according to ISO 10993-11)	Non-toxic
Acute Ocular Irritation	No ocular irritation (according to ISO 10993-10)	No ocular irritation
Shelf Life	Supports substantial equivalence	Supports substantial equivalence

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of this 510(k) submission for a contact lens. The "test set" here refers to the samples of the device material and finished product used for pre-clinical testing, not a dataset of patient images or clinical outcomes for an AI algorithm. The document does not specify exact sample sizes for each physicochemical or toxicology test, but it states that "A series of preclinical testing was performed," and "All non-clinical toxicology tests were conducted in accordance with the GLP regulation." The applicant is Vision Science Co., Ltd. in Gyeongsan-si, Gyeongsangbuk-do, South Korea, implying the testing likely originated there or was contracted to relevant labs. The data is prospective for these lab tests.

3. 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)

This information is not applicable. The "ground truth" for contact lens material properties is established through standardized laboratory testing (e.g., ISO standards, specific analytical methods like revised Fatt method for Dk). The "experts" are the technicians and scientists performing these tests, and their qualifications are adherence to GLP regulations and standard analytical procedures, rather than medical expertise in interpreting clinical images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for human interpretation of clinical or imaging data in diagnostic AI studies. For contact lens material testing, the results are typically quantitative measurements from instruments or qualitative observations from standardized tests, which do not involve expert adjudication in that manner.

5. 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

This information is not applicable. MRMC studies are relevant for diagnostic or screening devices, particularly those involving AI assistance to human readers. This document is for a medical device (contact lens) and does not involve AI or human reader interpretation in the context of a diagnostic task.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This document is for a physical medical device (contact lens), not an AI algorithm. Therefore, "standalone" algorithm performance is not a relevant concept here.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the contact lens refers to the objectively measured material properties (e.g., water content, oxygen permeability, refractive index, tensile strength) and the results of toxicology tests following recognized standards (ISO 10993). This is established through:

Standardized laboratory methods and measurements: for physicochemical properties.
Compliance with GLP regulations and ISO standards: for toxicology tests (cytotoxicity, systemic toxicity, acute ocular irritation).
Comparison to established properties of predicate devices: demonstrating substantial equivalence.

8. The sample size for the training set

This information is not applicable. This document is not about an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established

This information is not applicable. As there is no AI algorithm or training set, this question is not relevant.

Summary

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Image /page/0/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 a stylized image of an eagle with three human profiles incorporated into its body.

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

August 26, 2016

Vision Science Co., Ltd. % Mr. Bret Andre Consultant/Official Correspondent EyeReg Consulting, Inc. 6119 Canter Ln. West Linn. OR 97068

Re: K161124

Trade/Device Name: EYEREVE (hioxifilcon D) 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, MVN Dated: July 13, 2016 Received: July 18, 2016

Dear Mr. Andre:

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. 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 may be subject to 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.

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Page 2 - Mr. Bret Andre

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); medical device 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Alexander

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

Center for Devices and Radiological Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use (Describe)

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed for daily disposable wear the lens is to be discarded after each removal.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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:	K161124
Applicant information:
Date Prepared:	April 15th, 2016
Name:Address	VISION SCIENCE CO., LTD.7, Jain-Ro 7-Gil, Jain-myeonGyeongsan-si, Gyeongsangbuk-do,South Korea 712852
Contact Person:	Oh, In-WhanPresident
Phone number:	+82-53-857-3578
Consultant:	Bret J AndreEyeReg Consulting, Inc.6119 Canter LnWest Linn, OR 97068United States(503) 372-5226
Device Information:
Device Classification:	Class II
Classification Number:	LPL; MVN
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Trade Name:	EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lensfor Daily Wear

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Predicate Devices:

The EYEREVE (hioxifilcon D) Soft Contact Lenses are substantially equivalent to the following predicate device(s):

"Extreme H2O 54% (hioxifilcon D) Soft Contact Lens" Hydrogel Vision Corporation 510(k) number; K051430

"Clalen 54 (Hioxifilcon D) Soft Contact Lens" Interojo Inc. 510(k) number; K153766

"ISENS (polymacon)" ~ Reference Predicate Vision Science Co., Ltd. 510(k) number; K132714

"55 UV (methafilcon A)" ~ Reference Predicate Optical Connection Inc. 510(k) number; K051095

Device Description:

o >95% in the UVB range of 280nm 315nm
o >67% in the UVA range of 316nm 380mm.

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Name of Colorant	Listing
Titanium Dioxide	21 CFR § 73.3126
Phthalocyanine Green	21 CFR § 73.3124
Carbazole Violet	21 CFR § 73.3107
Reactive Blue 19	21 CFR § 73.3127
C.I. Reactive black 5	21 CFR § 73.3127

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 54% water by weight. The physical properties of the lens are:

Refractive Index	1.40 (hydrated)
Light Transmission	greater than 98%
Light Transmission (tinted)	greater than 96% (at region corresponding to pupil);Opaque or 0-10% (at region corresponding to iris)
Water Content	54 % ± 2%
Oxygen Permeability	21.50 X 10-11 (cm²/sec) (ml O2/ml x mm Hg @ 35°C)

The EYEREVE soft contact lenses will be manufactured in the sphere and toric design configurations with the following features and properties:

Chord Diameter:	12.80 mm to 15.00 mm
Center Thickness:	0.050 mm to 0.210 mm
Base Curve:	8.0 mm to 9.8 mm
Power Range
- Sphere Power:	-20.00D to +20.00D in 0.25D steps
- Cylinder Power (toric):	-0.25D to -4.00D in 0.25D steps
- Cylinder Axis (toric):	10° to 180° in 10° steps

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Indications for Use:

The EYEREVE (hioxifileon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

Daily wear replacement schedules may vary from patient to patient and should be decided by eye care practitioners in consultation with their patients.

Frequent/Planned Replacement Wear:

Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear. with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When Prescribed for daily disposable wear the lens is to be discarded after each removal.

Pre-Clinical Performance:

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the EYEREVE (hioxifilcon D) finished contact lenses. The results support the claim that the EYEREVE (hioxifilcon D) Soft Contact Lenses are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.

Toxicology:

All non-clinical toxicology tests were conducted in accordance with the GLP regulation.

In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the test article is non-toxic.

Systemic Toxicity: The lens material meets the requirements of the systemic injection test in accordance with ISO 10993-11 and is considered non-toxic.

Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation.

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Shelf Life

The data presented supports substantial equivalence of the EYEREVE (hioxifilcon D) finished contact lenses to the already marketed predicate devices.

Physicochemical & Mechanical Properties

The following tests were completed to verify substantial equivalence: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical property testing demonstrate consistent material properties between the EYEREVE (hioxifilcon D) contact lenses and the predicate devices.

Substantial Equivalence:

The EYEREVE (hioxifilcon D) soft contact lenses will be manufactured according to specified process controls and a cGMP quality assurance program currently in place as established by the ISENS reference predicate device (K132714).

The final packaging and sterilization of the EYEREVE (hioxifilcon D) soft contact lenses will be carried out in accordance with procedures specified for the ISENS reference predicate device (K132714).

The EYEREVE (hioxifilcon D) soft contact lenses are substantially equivalent to the predicate device as depicted in the following table, and do not raise different questions of safety and effectiveness than the predicate device identified previously.

The following table depicts the pre-clinical characteristics of the EYEREVE (hioxifilcon D) materials, as well as the predicate devices.

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Substantial Equivalence Matrix

	Vision ScienceCo., Ltd.EYEREVE(Subject Device)	Hydrogel VisionCorp.Extreme H2O54% (PredicateDevice)	Interojo Inc.Clalen 54(Predicate Device)	Vision ScienceCo., Ltd.ISENS(PredicateDevice)	OpticalConnectionUV 55(PredicateDevice)
Intended Use	Indicated for dailywear for the correctionof refractive error inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopia.	Indicated for daily wearfor the correction ofrefractive error inaphakic and notaphakic persons withnon-diseased eyes withmyopia or hyperopia.	Indicated for daily wearfor the correction ofrefractive error in aphakicand not aphakic personswith non-diseased eyeswith myopia or hyperopia.	Indicated for dailywear for thecorrection ofrefractive error inaphakic and notaphakic persons withnon-diseased eyeswith myopia orhyperopia.	Indicated for dailywear for thecorrection ofrefractive error inaphakic and notaphakic persons withnon-diseased eyeswith myopia orhyperopia.
Functionality	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina	The contact lenses actas a refractive mediumthat focus light raysfrom near and distantobjects on the retina	The contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina	The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina	The contact lenses actas a refractivemedium that focuslight rays from nearand distant objects onthe retina
Indications	Soft (hydrophilic)Contact Lens (21CFR 886.5925)	Soft (hydrophilic)Contact Lens (21CFR 886.5925)	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic)Contact Lens (21CFR 886.5925)	Soft (hydrophilic)Contact Lens (21CFR 886.5925)
ProductionMethod	Fully molded	Fully molded	Fully molded	Fully molded	Fully molded
USAN name	hioxifilcon D	hioxifilcon D	hioxifilcon D	polymacon	methafilcon A
Water Content(%)	54±2%	54±2%	54±2%	38±2%	55±2%
OxygenPermeability	$21.50 x 10^{-11}$(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C))(revised Fatt method)	$14.86 x 10^{-11}$(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C))(revised Fatt method)	$18.42 x 10^{-11}$(cm²/sec)(mlO₂)/(mlx mmHg @ 35°C))(revised Fattmethod)	$12.48 x 10^{-11}$(cm²/sec)(mlO₂)/(mlx mmHg @ 35°C))(revised Fattmethod)	$18.90 x 10^{-11}$(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C))(revised Fatt method)
FDA Group	FDA Group 2(>50% H₂O, non-ionic polymer)	FDA Group 2(>50% H₂O, non-ionic polymer)	FDA Group 2(>50% H₂O, non-ionic polymer)	FDA Group 1(<50% H₂O,non-ionicpolymer)	FDA Group 2(>50% H₂O, non-ionic polymer)
RefractiveIndex(hydrated)	1.40	1.41	1.40	1.43	1.41
UV Blocker	Yes	No	Yes	No	Yes

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.