The ISENS (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity 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 .50 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 ISENS (polymacon) Toric Soft Contact Lenses for daily wear are indicated 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 4.00 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 Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Device Description

The ISENS soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. All lenses containing dioptric powers outside +/- 10.00 D and toric lenses are lathe-cut to specified R.J. The ISENS soft contact lenses are fabricated from polymacon, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material, (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The (polymacon) name has been adopted by the United States Adopted Names Council (USAN).

ISENS lenses are available clear, visibility tinted, and cosmetically tinted. Lenses are tinted with one or a combination of one or more of the following 'listed' color additives: D&C Red 17, D&C Violet 2, D&C Yellow 10, Titanium Dioxide, Iron Oxide (Red), [Phthalocyaninato(2-)] Copper, Phthalocyanine Green, Carbazole Violet, Reactive Blue 19, and C.I. Reactive black 5. 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 cosmetic 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. As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove unbound reactive color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The cosmetic 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 transparent or colored optical surface. The (polymacon) 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; it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are:

Refractive Index: 1.43
Light Transmission (clear): greater than 96%
Light Transmission (tinted): greater than 96% (at clear region corresponding to pupil, standard 6.0 mm diameter); Opaque or 0-10% (at tinted region corresponding to iris)
Surface Character: hydrophilic
Water Content: 38±2%
Specific Gravity: 1.17 (hydrated)
Oxygen Permeability: 12.48 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method)

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in spherical and toric 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
Cast-molded: -10.00D to +10.00D in 0.25D steps
Lathe-cut: -20.00D to -10.00D & +20.00D to +10.00D in 0.25D steps
Cylinder Power (Toric): -0.25D to -4.00D in 0.25D steps (lathe-cut)
Cylinder Axis (Toric): 10° to 180° in 10° steps

Cast-molded lenses ISENS lenses are supplied sterile in blister packages with a base made from polypropylene and a laminated foil seal on top. Lathe-cut ISENS lenses are supplied sterile in vials containing saline solution with preservative Polyhexamethylene Biguanide (PHMB). Blister package and vial labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

AI/ML Overview

The provided text describes a 510(k) premarket notification for ISENS (polymacon) Spherical and Toric Daily Wear Soft Contact Lenses. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria.

Therefore, many of the requested categories cannot be directly extracted from the provided text. However, I can synthesize the available information.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for a specific study, as well as distinct "reported device performance" from a new study, is not explicitly detailed in the document in the format usually seen for AI/medical imaging device submissions. Instead, the document focuses on demonstrating substantial equivalence to predicate devices. The performance criteria are implicitly related to the established safety and effectiveness of the legally marketed predicate devices and physical/material properties.

However, we can infer some "performance" metrics by looking at the physical properties.

Characteristic	Acceptance Criteria (Implied/Predicate Range)	Reported Device Performance (ISENS)
Refractive Index	N/A (compared to predicate values)	1.43
Light Transmission	>96% (clear); Opaque/0-10% (tinted)	>96% (clear); Opaque/0-10% (tinted)
Surface Character	Hydrophilic	Hydrophilic
Water Content	38 ± 2%	38 ± 2%
Specific Gravity	1.17 - 1.20 (hydrated, from predicates)	1.17 (hydrated)
Oxygen Permeability	7.93 - 12.48 x 10⁻¹¹ (from predicates)	12.48 x 10⁻¹¹
Chord Diameter Range	N/A (compared to predicate designs)	12.80 mm to 15.00 mm
Center Thickness Range	N/A (compared to predicate designs)	0.050 mm to 0.210 mm
Base Curve Range	N/A (compared to predicate designs)	8.0 mm to 9.8 mm
Power Range (Spherical)	N/A (compared to predicate designs)	-20.00D to +20.00D
Cylinder Power (Toric)	N/A (compared to predicate designs)	-0.25D to -4.00D
Cylinder Axis (Toric)	N/A (compared to predicate designs)	10° to 180°
Sterility	Sterile for indicated shelf-life	Sterile for indicated shelf-life
Packaging Material	Non-toxic and non-irritating	Non-toxic and non-irritating
Physical/Material Props	Consistent with marketed lenses	Consistent with marketed lenses

Note: The "acceptance criteria" here are inferred from the comparisons made to predicate devices and the statements about consistency. The actual predicate ranges are derived from the "Substantial Equivalence Matrix" (page 5).

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k)." (Page 4).

This indicates that no new clinical "test set" study was conducted for this 510(k) submission to demonstrate the performance of the ISENS device. The data provenance for the material's established performance would, therefore, be from the original studies of the polymacon material, likely going back to the predicate devices or earlier material approvals, which are not detailed here.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

As no new clinical "test set" study was conducted, this information is not applicable. Ground truth assessment by experts for performance evaluation was not part of this specific submission.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical "test set" study was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission relies on substantial equivalence to predicate devices, and explicitly states that clinical performance of the material was previously established.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

Not applicable, as this is a contact lens device, not an algorithm or AI system. The "performance" being evaluated is related to physical properties, biocompatibility, and functionality for vision correction, not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing (in vitro and in vivo toxicology, biocompatibility, sterility, shelf-life, physical/material properties), the "ground truth" would be established by standard scientific protocols, laboratory measurements, and regulatory standards (e.g., GLP regulations, ISO standards for materials, etc.). This is not ground truth in the sense of expert consensus for diagnostic interpretation.

For the claim of safety and effectiveness, the ground truth relies on the established safety and effectiveness of the predicate polymacon contact lenses and the historical data supporting the polymacon material itself.

8. The Sample Size for the Training Set

Not applicable, as the device is not an AI/ML algorithm requiring a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as the device is not an AI/ML algorithm requiring a "training set."

Summary

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MAR 0 5 2014

Vision Science Co., Ltd.

510(K) Premarket Notification

Page 1 of 6

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.

K132714 The assigned 510(k) number is:

Applicant information:

Date Prepared:	2/26/2014
Name:	Vision Science Co., Ltd.1092-7, Buksa-ri,Jain-Myeon, Gyeongsan-si,Gyeongsangbuk-do, 712-852South Korea
Contact Person:	Mr. Oh, In-WhanPresident
Phone number:	+82-53-857-3578
Consultant:	Bret J AndreEyeReg Consulting, Inc.21225 NW Wilkins St.Beaverton, OR 97006United States
Phone number:	(503) 372-5226
Device Information:
Device Classification:	Class II
Product Code:	LPL; MVN
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Trade Name:	ISENS (polymacon) Spherical and Toric Daily WearSoft (hydrophilic) Contact Lenses (Clear and Tinted)

ISENS (polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear and Tinted)

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Equivalent Devices:

ISENS (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) are substantially equivalent to the following predicate devices:

Predicate devices:

"Biomedics38" . By Coopervision PMA number; P780007
. "Contaflex 38" By Contamac Ltd. 510(k) number; K023987
"Aquamax" . By Pegavision Corporation 510(k) number; K123973

Device Description:

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The physical properties of the lens are:

Refractive Index	1.43
Light Transmission (clear)	greater than 96%
Light Transmission (tinted)	greater than 96% (at clear region corresponding to pupil,standard 6.0 mm diameter);Opaque or 0-10% (at tinted region corresponding to iris)
Surface Character	hydrophilic
Water Content	38±2%
Specific Gravity	1.17 (hydrated)
Oxygen Permeability	$12.48 \times 10^{-11}$ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revisedFatt method)

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
Cast-molded:	-10.00D to +10.00D in 0.25D steps
Lathe-cut:	-20.00D to -10.00D & +20.00D to +10.00D in 0.25D steps
Cylinder Power (Toric):	-0.25D to -4.00D in 0.25D steps (lathe-cut)
Cylinder Axis (Toric):	10° to 180° in 10° steps

ISENS (polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear and Tinted)

{3}------------------------------------------------

Intended Use:

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:

Testing:

Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the ISENS (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses packaged in blister packages or glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols.

Test results of the non-clinical testing on the ISENS (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses demonstrate that:

Lenses supplied in blister packages and glass vials are sterile for the . indicated shelf-life,
The packaging material and extracts are not toxic and not irritating, . and
Lens physical and material properties are consistent with currently . marketed lenses.

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Clinical Data The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k).

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the ISENS, (polymacon) Spherical and Toric Soft Contact Lenses for Daily Wear is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of daily wear soft contact lenses. The benefits to the patient are the same as those for other daily wear soft contact lenses.

Substantial Equivalence:

The ISENS Soft Contact Lens will be manufactured according to specified process controls and a cGMP quality assurance program currently in place. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the ISENS contact lens material is equivalent to the predicate devices identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

The following matrix illustrates the equivalencies of the ISENS Spherical and Toric Soft (hydrophilic) Contact Lens, as well as the substantial equivalent predicate devices.

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Vision Science Co., Ltd.

510(K) Premarket Notification

Substantial Equivalence Matrix

	Vision Science Co. Itd.,ISENS (polymacon)New Device	CoopervisionBiomedics38(polymacon)Predicate Device	PegavisionCorporationAquamax(polymacon)Predicate Device	Contamac Itd.Contaflex38(polymacon)Predicate Device
Intended Use	Indicated for daily wear for thecorrection of visual acuity inaphakic and not aphakic personswith non-diseased eyes withmyopia or hyperopia and/orpossesses refractive astigmatismnot exceeding 4.00 diopters.NOTE: refractive astigmatismN/A for spherical lenses.	Indicated for daily wear forthe correction of visualacuity in aphakic and notaphakic persons with non-diseased eyes with myopiaor hyperopia and/orpossesses refractiveastigmatism not exceeding4.00 diopters. NOTE:refractive astigmatism N/Afor spherical lenses.	Indicated for daily wearfor the correction ofvisual acuity in aphakicand not aphakic personswith non-diseased eyeswith myopia or hyperopiaand/or possessesrefractive astigmatism notexceeding 2.00 diopters.NOTE: refractiveastigmatism N/A forspherical lenses.	Indicated for daily wear forthe correction of visualacuity in aphakic and notaphakic persons with non-diseased eyes with myopiaor hyperopia and/orpossesses refractiveastigmatism not exceeding4.00 diopters. NOTE:refractive astigmatism N/Afor spherical lenses.
Functionality	Same as predicate device	The contact lenses actas a refractivemedium that focuslight rays from nearand distant objects onthe retina	The contact lensesact as a refractive.medium 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	Daily Wear, Soft(hydrophilic) ContactLens	Daily Wear, Soft(hydrophilic) ContactLens	Daily Wear, Soft(hydrophilic)Contact Lens	Daily Wear, Soft(hydrophilic) ContactLens
ProductionMethod	Fully-molded(lathe-cut for specified powersoutside +/- 10.00 D)	Fully-molded	Fully-molded	Lathe-Cut
USAN name	polymacon	polymacon	polymacon	polymacon
Water Content(%)	38±2%	38±2%	38±2%	38±2%
OxygenPermeability	12.48 x 10-11(cm²/sec)(mlO₂)/(ml x mmHg @35°C)) (revised Fatt method)	8.40 x 10-11(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C)) (revisedFatt method)	12.10 x 10-11(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C)) (revisedFatt method)	7.93 x 10-11(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C)) (revisedFatt method
Specific Gravity	1.17 (hydrated)	1.20 (hydrated)	-	1.17 (hydrated)

ISENS (polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear and Tinted)

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Public Health Service

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's stylized logo, which consists of three overlapping, abstract shapes resembling human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.

DEPARTMENT OF HEALTH & HUMAN SERVICES

March 5. 2014

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

Vision Science Co., Ltd. % Mr. Bret Andre. MS, ABOc EyeReg Consulting, Inc. 21225 NW Wilkins Street Beaverton, OR 97006

Re: K132714

Trade Name: ISENS (polymacon) Spherical and Toric Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Codes: LPL, MVN

Dated: January 22, 2014 Reccived: January 24. 2014

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 warrantics. 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.

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.

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Page 2 - Mr. Bret Andre

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

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 Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K132714

Device Name

ISENS (polymacon) Spherical and Toric Daily Wear Soft Contact Lenses (Clear and Tinted)

Indications for Use (Describe)

The ISENS (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual aculty in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit on fractive assigmatism of .50 diopters or less where the astigmatism does not interfere with visual aculty. The lens is available vear octived and may be used to enhance or alter the apparent color of the eye.

The ISENS (polymacon) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non diseased eyes with myopia or hyperopia and/or possesses refractive assigmatism not exceeding 4.00 diopters. The lens is available clear or tinted and may be used to enhance or aller the apparent color of the eye.

Dally wear replacement schedules may vary from patient and should be decided by eyecare practifioners in onsultation with their patients.

Frequent/Planned Replacement Wear:

Disposable Wear:

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

2 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)

Marc W. Robbov -S 2014.02.24 10:20:52 -05'00'

FORM FDA 3881 (9/13)

{9}------------------------------------------------

This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gether and mainlain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.