The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The SAUFLON CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.

The SAUFLON CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopers or less and may exhibit astigmatism up to 1.50 Diopters or less.

The SAUFLON CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +4.00 Diopters or less.

Sauflon Clariti 1 Day (somolilcon A) Soft (hydrophilic) Daily Disposable Contact lens. with UV blocker and Handling Tim help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is available as a single vision, toric, multifocal and multifocal toric lens. The lens muterial (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate. When hydrated the lens consists of 44.0% somofileon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used to block UV radiation. A handling tint is added to the composition of the lens to make the lens visible for handling.

The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm

The Sauflon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent schera, with the following dimensions:

Chord Diameter: 13.0mm to 18.0mm
Centre Thickness: 0.03mm to 0.70mm
Base Curve: 7.5mm to 9.50mm
Powers: -30.00 DS to +30.00 DS
Toric Cylinder options: -0.75 to -9.75
Toric Axis options: 10° to 180° (5° steps).
Multifocal Add: Add power up to +4.00 labelled with indicative add strength to be read in conjunction with the fitting guide.

The physical/optical properties of the lenses are:

Refractive Index: 1.4008
%Transmittance @ 590nm: 98.30
%Transmittance @ 280-315nm: 0.71
%Transmittance @ 316-380nm: 20.62
Surface Character: Hydrophilic
Water Content: 56%
Oxygen Permeability (DK): 60 x 10-11 (cm²/sec) (ml O2/ml x mmHg) at 35°C (Fatt Method for determination of oxygen permeability).
Specific Gravity: 1.17

AI/ML Overview

The provided 510(k) summary for the SAUFLON CLARITI I DAY TINTED CONTACT LENS primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of physical, optical, and chemical properties, as well as toxicology and human clinical studies. However, it does not explicitly define "acceptance criteria" in the traditional sense of specific performance metrics with binary outcomes for the device itself. Instead, the "acceptance criteria" can be inferred as demonstration of safety, efficacy, and substantial equivalence to existing legally marketed devices.

The study that "proves the device meets the acceptance criteria" is described as a "clinical study" which evaluated "the safety and efficacy" and "substantial equivalence" of the Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

Since explicit "acceptance criteria" with numerical targets are not stated, the table below infers them based on the substantial equivalence claims and the type of information presented. The reported performance is the conclusion of the studies.

Acceptance Criteria (Inferred)	Reported Device Performance
Physical/Optical/Chemical Properties:	Substantially equivalent to predicate devices. Specific properties are listed with values that are either identical or comparable to predicate devices (e.g., Water Content 56%, Refractive Index 1.40, Light Transmittance ≥96%, Dk @35°C 60).
- Water Content	56%
- Refractive Index	1.40
- Light Transmittance	≥96%
- Oxygen Permeability (Dk)	60 x 10^-11 (cm²/sec) (ml O2/ml x mmHg) at 35°C
- Leachable substances levels	Low or below measurable levels.
Biocompatibility/Toxicology:	Passed ISO 10993 standards. No evidence of adverse clinical effects caused by the lens across cytotoxicity, ocular irritation, and systemic toxicity assessments.
- Cytotoxicity (ISO 10993)	Passed
- Ocular Irritation (ISO 10993)	Passed
- Systemic Toxicity (ISO 10993)	Passed
Clinical Safety and Efficacy:	Demonstrated safety, acceptability, and substantial equivalence to the predicate device (Air Optix Aqua) for its intended use through a human clinical study. The study showed "no evidence of adverse clinical effects."
- Acceptable safety profile (no adverse clinical effects)	Achieved ("no evidence of adverse clinical effects caused by the lens" and "the safety, acceptability and substantial equivalence... to the predicate device for its intended use")
- Efficacy for intended use (refractive correction, UV blockage)	Achieved (Inferred from "substantial equivalence... to the predicate device for its intended use" and the specific UV transmittance characteristics that are stated for the device (less than 5% in UVB, less than 50% in UVA), which meet typical Class 2 UV blocker requirements for contact lenses, although not an explicit acceptance criterion).
- Substantial Equivalence to Predicate Devices (Air Optix Aqua, Acuvue Trueye, Sauflon Clariti 1 Day)	Concluded by the sponsor and FDA (via 510(k) clearance) based on the comprehensive evaluation, including physical/optical properties, toxicology, and clinical study findings.

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

Sample size for the human clinical study: Not explicitly stated. The text only mentions "Subjects" were used.
Data provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, clinical studies conducted for 510(k) submissions are typically prospective and often involve participants from various regions, though this document doesn't specify.

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)

The document does not mention the number or qualifications of experts used to establish ground truth for the clinical study. Such detail is typically found within the full clinical study report, not necessarily in a 510(k) summary. Given the nature of a contact lens study, the "ground truth" would likely be derived from direct clinical observations, objective measurements (e.g., visual acuity, fits assessment), and reported symptoms by the subjects, assessed by optometrists or ophthalmologists.

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

The document does not describe any specific adjudication method for the clinical study data.

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

No MRMC comparative effectiveness study was done. This type of study is not relevant for a contact lens approval, as it's for evaluating diagnostic aids or imaging interpretation, not the physical performance of a medical device like a contact lens.

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

This question is not applicable. The device is a contact lens, meaning it is a physical product designed for human wear, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept here.

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

For the human clinical study, the "ground truth" would be clinical observations and measurements related to safety (e.g., ocular health, adverse events) and efficacy/acceptability (e.g., visual acuity, comfort, fit, patient preference, manifest refraction/prescription as a baseline). This is effectively outcomes data from the subjects themselves, assessed by clinicians.
For the physicochemical studies, the "ground truth" is established by standard laboratory test methods (e.g., Fatt Method for oxygen permeability measurement).

8. The sample size for the training set

This question is not applicable as this is a physical medical device (contact lens) and not an AI/ML algorithm that requires a "training set."

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

This question is not applicable as there is no "training set" for this device.

Summary

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SAUFLON CLARITI I DAY TINTED CONTACT LEÑS 510(k)

MAR 04 2014
K133472

510(K) SUMMARY AS REQUIRED BY SECTION 807.92(c)

1.- SUBMITTER INFORMATION:

Sauflon Pharmaceuticals Ltd. Company Name:

49-53 York Street Address: Twickenham Middlesex TWI 3LP

020 8322 4200 Phone:

Fax: 020 8891 2833

Contact Person: Dr Christopher Smejkal

DATE SUMMARY PREPARED: 15th October 2013

DEVICE NAME:

Trade Name:	Sauflon Clariti 1 Day (somofilcon A) Soft(hydrophilic) Daily Disposable Contact Lens with UVBlocker and Handling Tint
Common Name:	Soft Contact Lens
Classification:	CLASS 11 (21 CFR 886.5925) CODE -LPL, MVNSOFT (HYDROPHILIC) CONTACT LENS
Duration of Contact:	A daily replacement lens for surface contact of the eyeand intended for daily removal and less than 24 hourscontact duration.

2.- SUBSTANTIAL ÉQUIVALENCE:

The sponsor considers the Sauflon Clariti 1 Day (somofilcon. A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint to be substantially cquivalent to the Sauffon Clariti 1 Day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker, cleared pursuant to K 130331. Acuvue Trueye (Narafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K073485, and Air Optix (Lotrafilcon B) Soft (Hydrophilic) Visibility Timed Contact Lens for Daily Wear which has been approved pursuant to K033919/K073459.

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SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k)

3 .- DESCRIPTION of the DEVICE:

The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm

Chord Diameter:	13.0mm to 18.0mm
Centre Thickness:	0.03mm to 0.70mm
Base Curve:	7.5mm to 9.50mm
Powers:	-30.00 DS to +30.00 DS
Toric Cylinder options:	-0.75 to -9.75
Toric Axis options:	10° to 180° (5° steps).

Multifocal Add: .

Add power up to +4.00 labelled with indicative add strength to be read in conjunction with the fitting guide.

The physical/optical properties of the lenses are:

• Refractive Index:	1.4008
• %Transmittance @ 590nm:	98.30
• %Transmittance @ 280-315nm:	0.71
• %Transmittance @ 316-380nm:	20.62
• Surface Character:	Hydrophilic
• Water Content:	56%
• Oxygen Permeability (DK):	60 x 10-11 (cm²/sec) (ml O2/ml x mmHg)at 35°C (Fatt Method for determinationof oxygen permeability).
• Specific Gravity:	1.17

4 .- INDICATIONS FOR USE

Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for:

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SAUFLON CLARITI 1 DAY TINTED CONTACT LENS 510(k)

The SAUFLON CLARITI 1 DAY (somotilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The SAUFLON CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia-and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.

5 .- PREDICATE DEVICES

The sponsor considers the SAUFLON CLARITI IDAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint to be substantially equivalent to the SAUFLON CLARIT IDAY (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker cleared pursuant to K130331, Acuvue Trueye (Narafilcon A) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear single use which has been approved pursuant to K073485, and Air Optix (Lotrafileon B) Soft (hydrophilic) Visibility Tinted Contact Lens for Daily Wear which has been approved pursuant to K033919/K073459.

The following table summarises the primary features for this comparison, illustrating the similarities and differences.

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SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k)

			Comparison of Physical / Optical Properties for the SAUFLON CLARITI 1 DAY (somofilcon A) Silicone Hydrogel Contact Lens with UVBlocker and handling tint versus Acuvue Trueye (Narafilcon A) and SAUFLON CLARITI I DAY SILICONE HYDROGEL
LENS MATERIAL	PREDICATE DEVICE - ACUVUETRUEYE (K073485)	PREDICATE DEVICE - SAUFLON CLARITI1 DAY SILICONE HYDROGEL (K130331)	SUBJECT DEVICE- SAUFLON CLARITI 1 DAYWITH HANDLING TINT
narafilcon A Silicone Hydrogel		somofilcon A Silicone Hydrogel	somofilcon A Silicone Hydrogel
INDICATIONS FORUSE	Daily wear single use	Daily wear single use	Daily wear single use
MANUFACTURINGPROCESS	Cast Moulding	Cast Moulding	Cast Moulding
WATER CONTENT	47%	56%	56%
REFRACTIVEINDEX	1.41	1.40	1.40
LIGHTTRANSMITTANCE	85% minimum	≥96%	≥96%
DK @35°C (EDGECORRECTED)	100 (polarographic method)	60 (Coulometric method)	60 (polarographic method)
COLOUR	Blue Visibility Tint	No Visibility Tint	Blue Visibility Tint

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SAUFLON CLARITT I DAY TINTED CONTACT LENS 510(K)

TINT	UV BLOCKER	MODULUS (MPa)	TENSILE STRENGTH (MPa)	ELONGATION AT BREAK %	PACKAGING MATERIALS	PACKAGING SOLUTION	PACKAGING METHOD
CI Reactive Blue Dye 4	Benzotriazole	0.66	0.72	170	Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons	Buffered saline solution containing up to 0.01% methyl ether cellulose	Hermetically sealed blister pack
none	Benzophenone	0.55	1.05	163	Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons	Borate buffered saline solution containing 0.005% poloxamer	Hermetically sealed blister pack
D&C Green No. 6	Benzophenone	0.55	1.05	163	Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons	Borate buffered saline solution containing 0.005% poloxamer	Hermetically sealed blister pack

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SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k).

6 .- PHYSICOCHEMICAL STUDIES

The physical; optical and chemical properties of the lenses as assessed by various test methods show substantial equivalency with the predicate devices as illustrated in the preceding table. Studies were also conducted to verify that leachable substances were either low or below measurable levels to assuage any concerns for its intended use.

7 .- TOXICOLOGY STUDIES

Sauffon Clariti (somofilcon A) Soft (hydrophilic) Contact Lenses with UV Blocker and Handling Tint was assessed using ISO 10993 standards for cytotoxicity, ocular irritation and systemic toxicity. All results passed with no evidence of adverse clinical effects caused by the lens.

8 .- HUMAN CLINICAL STUDIES

A clinical study was conducted to evaluate the safety and efficacy of Sauflon Clariti (somofileon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint by comparison with Air Optix Aqua hydrophilie contact lenses (Ciba Vision Inc.). Subjects used OptiFree Replenish solution (Alcon Laboratories Inc.) for daily lens maintenance, care and storage. The results of this study showed the safety, acceptability and substantial equivalence of the Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint to the predicate device for its intended use.

9 .- CONCLUSIONS

Based on the above evaluations the Sauflon Clariti 1 day (somofileon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint is substantially equivalent to the predicate, marketed lenses. Based on these evaluations the Sauflon Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint has been shown to be safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

March 4, 2014

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

Sauflon Pharmaceuticals Ltd % Dr. Christopher Smejkal Head of Regulatory and Technical Affairs 49-53 York Street, Twickenham Middlesex TW1 3LP United Kingdom

Re: K133472

Trade/Device Name: Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker and Handling Tint Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 22, 2014 Received: January 30, 2014

Dear Dr. Smejkal:

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 I ou may atorely mains 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,

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 - Dr. Christopher Smejkal

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 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/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 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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SAUFLON CLARITI I DAY TINTED CONTACT LENS 510(k)

. ......

INDICATIONS FOR USE

510(k) Number (if known): K133472
Device Name:	Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) DailyDisposable Contact Lens with UV blocker and Handling Tint.
Indication for use:	The Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic)Daily Disposable Contact Lens with handling tint is indicatedfor:

The SAUFLON CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

The SAUFLON CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-discased eyes that may exhibit astigmatism up to 10.00 Diopters.

The SAUFLON CLARITI I DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker and Handling Tint is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.

The SAUFLON CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +4.00 Diopters or less.

Sauflon Clariti 1 Day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact lens with UV blocker and Handling Tint help protect against transmission of harmful UV radiation to the cornea and into the eye.

7 Prescription Use (Part 21 CFR 801 Subpari D)

Over-The-Counter Use (2) CFR 801 Subpart C)

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

AND/OR

Alexander Bevl 2014.02 :20 09:37:20 -05'00'

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.