The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon removal.

Device Description

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is available as aspherical lenses manufactured by cast-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.

AI/ML Overview

The provided text describes the submission of a 510(k) premarket notification for the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens." This notification aims to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove the device meets specific acceptance criteria as one might find for an AI/ML medical device.

Therefore, the requested information elements related to AI/ML device testing (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or mentioned in this document. This submission focuses on the physical and chemical properties and biocompatibility of a contact lens compared to a predicate device.

Below, I've extracted the closest relevant information regarding "acceptance criteria" (which are generally product specifications and compliance with standards) and "reported device performance" based on the provided text.

Acceptance Criteria and Reported Device Performance for Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

This submission establishes substantial equivalence for the Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens to a predicate device (Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens). The "acceptance criteria" are implied by the product specifications and compliance with various international standards for contact lenses, which were met by the device.

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

The document provides a comparison of specifications between the subject device and the predicate device. The "reported device performance" are the physical and chemical properties of the Unicon Hydrogel contact lens. The acceptance criteria are essentially that these properties, or test results, meet established standards and are substantially equivalent to the predicate.

Item / Property	Subject Device (Unicon Hydrogel) Performance	Predicate Device (Tangible Hydrogel) Performance	Substantial Equivalence Determination (Acceptance)
Intended Use	Optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Daily disposable wear.	Optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Daily disposable wear.	Same
Type of use	Prescription Use	Prescription Use	Same
Single Use	Yes	Yes	Same
UV Blocking	Yes (Avg<5% @ 280-315 nm, Avg<30% @ 316-380 nm)	Yes (Avg<5% @ 280-315 nm, Avg<30% @ 316-380 nm)	Same
Production Method	Cast-Molded	Cast-Molded	Same
USAN Name	etafilcon A	etafilcon A	Same
Color additive	RB246	[Phthalocyaninato(2-)]copper	Different, but RB246 is also approved; therefore it would not affect the equivalence.
Base Curve (mm)	7.85 to 10.0	7.85 to 10.0	Same
Chord Diameter (mm)	12.00 to 15.00	12.00 to 15.00	Same
Center Thickness (mm)	Varies with power (0.080 mm at -3.00D, 0.200 mm at +3.00D)	0.01 mm to 0.20 mm	Different, but the specification meets the requirement; therefore it would not affect the equivalence.
Water Content (%)	58 ± 2%	58%	Same
Refractive Index (hydrated)	1.400 ± 0.005	1.400	Same
Oxygen Permeability ($\times 10^{-11} (cm^2/sec)(mlO_2/ml-mmHg)$)	21 ± 20% (Reported: $23.42 \times 10^{-11}$)	$29.96 \times 10^{-11}$	Different, but the specification meets the requirement; therefore it would not affect the equivalence.
Power Range	+4.50D ~ +6.00D (0.50D steps), +4.00D ~ -6.00D (0.25D steps), -6.50D ~ -13.00D (0.50D steps)	+6.00D to -10.00D (0.25D steps) with Cyl/Axis/Add	Different, but it would not affect the equivalence.
Visible Light Transmittance (%)	95 ± 5%	>98%	Different, but the specification meets the requirement; therefore it would not affect the equivalence.
UV Transmittance (%)	At 280~~315 nm: Avg<5%, At 316~~380 nm: Avg<30%	At 280~~315 nm: Avg<5%, At 316~~380 nm: Avg<30%	Same

Additionally, the device met requirements for the following tests, demonstrating compliance with respective ISO and ASTM standards:

Sterilization test: Complies with ISO 17665-1:2006, ISO 11737-1:2018, ISO 11737-2:2009, and ISO 11138-3:2017.
Shelf life test: Complies with ISO 11987:2012 (E), ISO 18369-1:2006, ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ISO 17665-1:2006, and USP 32 – NF27 <71>.
Biocompatibility tests: Complies with ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-12:2012 for In Vitro Cytotoxicity, White Rabbit Ocular Irritation, and Acute Systemic Toxicity.
Performance tests (Humectant, Water Content, Transmittance, Refractive Index, Oxygen Permeability, Mechanical Properties, Extractables of Material Pigment, Extractables, pH Value, Osmolarity, Geometric Parameters, Specific Gravity): Complies with ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ANSI Z80.20-2004, ASTM D882:2002, and ASTM D1708-13.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "A series of non-clinical studies were completed on this product." However, specific sample sizes for each test are not provided in this summary. The tests were performed according to FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. Data provenance (country of origin, retrospective/prospective) is not specified for these non-clinical 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)
Not applicable. This is a contact lens submission primarily based on physical, chemical, and biological compatibility testing, not diagnostic AI/ML requiring expert ground truth for interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML diagnostic device.

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
Not applicable. This is not an AI/ML diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the non-clinical tests is based on established scientific and engineering principles, and validated measurement methods as described by the cited ISO, ASTM, ANSI, and USP standards. For example, water content is measured physically, and biocompatibility is assessed through standardized biological tests.

8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set. The device is a manufactured product tested for its inherent properties.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 16, 2019

UNICON Optical CO., LTD Hsiao-Wei Shen, Coordinator No 16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township Hsinchu County, 30075 TW

Re: K182734

Trade/Device Name: Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 15, 2019 Received: April 17, 2019

Dear Hsiao-Wei Shen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182734

Device Name

Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens

Indications for Use (Describe)

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism. Eye care professionals may prescribe the lenses for daily disposable wear. Lenses shall be discarded upon 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)	☐

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

510(k) SUMMARY

5.1	Type of Submission:	Traditional
5.2	Date of Summary:	May 14, 2019
5.3	Submitter:	UNICON Optical CO., LTD
	Address:	No 16, Gongye E. 9th Rd., Hsinchu Science Park,Baoshan Township, Hsinchu County 30075,Taiwan (R.O.C.)
	Phone:	+886-3-5775586
	Fax:	+886-3-5777868
	Contact:	HSIAO-WEI SHEN(ra@uniconvision.com.tw)

5.4 Identification of the Device:

Proprietary/Trade name:	Unicon Hydrogel (etafilcon A) Soft(Hydrophilic) Daily Disposable ContactLens
Classification Product Code:	LPL, MVN
Regulation Number:	886.5925
Regulation Description:	Soft (hydrophilic) contact lens
Review Panel:	Ophthalmic
Device Class:	II

ર્ રંડ Identification of the Predicate Device:

Predicate Device Name:	Tangible Hydrogel with Tangible Polymer(etafilcon A) ASPHERIC Soft(Hydrophilic) Daily Disposable ContactLens
Manufacturer:	Tangible Science LLC
Classification Product Code:	LPL, MVN
Regulation number:	886.5925

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Device Class:	II
510(k) Number:	K172692

5.6 Intended Use/ Indications for Use of the Device

5.7 Device Description

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with visible tint is light tinted blue using C.I Reactive Blue 246 to make the lens more visible for handling. The lenses also contain a UV absorber {2-[3-(2H-Benzotriazol-2-vl)-4-hydroxypheny]] ethyl methacrylate} which is included during the manufacturing process as an additive to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380 nm. With more specific explanation, the "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens" is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from

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-6.50D to -13.00D in 0.50D per step.

The properties of the lenses are:

●	Base Curve (mm):	7.85 to 10.0
●	Chord Diameter (mm):	12.00 to 15.00
●	Center Thickness (mm):	Varies with power0.080 mm at -3.00D0.200 mm at +3.00D
●	Power (D):	+6.00 to -13.00
●	Refractive Index (hydrated):	1.400 ±0.005
●	Water Content (%):	58±2%
●	Oxygen Permeability:(x10-11 (cm²/sec)(mlO₂/ml-mmHg))	21±20%
●	Visible Light Transmittance (%):	95±5%
●	UV Transmittance (%):	At 280~~315 nm: Avg<5%At 316~~380 nm: Avg<30%

5.8 Non-clinical Testing

A series of non-clinical studies were completed on this product. The tests and studies were according to the FDA guidance "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses, Issued May 1994" and related recognized consensus standards. All the test results met the requirements of products specification.

The following tests were conducted on "Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens":

· Sterilization test

Test results performed in test reports of sterilization test demonstrated that subject device complies with ISO 17665-1:2006, ISO 11737-1:2018, ISO 11737-2:2009, and ISO 11138-3:2017 requirements.

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. Shelf life test

Test results performed in test reports of shelf life test demonstrated that subject device complies with ISO 11987:2012 (E), ISO 18369-1:2006, ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ISO 17665-1:2006, and USP 32 – NF27 <71> requirements.

Biocompatibilitv tests .

In Vitro Cytotoxicity -
-White Rabbit Ocular Irritation
-Acute Systemic Toxicity

Tests were conducted in accordance with ISO 10993-1:2009, ISO 10993-2:2006, ISO 10993-5:2009, ISO 10993-10:2010, ISO 10993-11:2017, and ISO 10993-12:2012 requirements.

. Performance tests

Humectant -
Water Content -
Transmittance -
Refractive Index -
Oxygen Permeability -
Mechanical Properties of Materials -
Extractables of Material Pigment -
Extractables -
pH Value -
Osmolarity -
Geometric Parameters -
Specific Gravity -

Tests were conducted in accordance with ISO 18369-2:2012, ISO 18369-3:2017, ISO 18369-4:2017, ANSI Z80.20-2004, ASTM D882:2002, and ASTM D1708-13 requirements.

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5.9 Clinical Testing

The safety and effectiveness of finished contact lenses manufactured from the etafilcon A have been established through previous clinical performance testing. And the pre-clinical testing results are sufficient in establishing substantial equivalence.

5.10 Substantial Equivalence Determination

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens (K172692). Differences between the devices cited in this section do not raise any new issues of substantial equivalence.

Item	Subject device	Predicate device	Substantialequivalencedetermination
Proprietary Name	Unicon Hydrogel (etafilcon A) Soft(Hydrophilic) Daily DisposableContact Lens	Tangible Hydrogel with TangiblePolymer (etafilcon A) ASPHERICSoft (Hydrophilic) DailyDisposable Contact Lens	N/A
510(k) No.	K182734	K172692	N/A
Intended Use	The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes	The Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens is indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic	Same
Item	Subject device	Predicate device	Substantialequivalencedetermination
	who may have 1.00 D or less ofastigmatism. Eye care professionalsmay prescribe the lenses for dailydisposable wear. Lenses shall bediscarded upon removal.	persons with non-diseased eyeswho may have 1.00 D or less ofastigmatism. Eye care professionalsmay prescribe the lenses for dailydisposable wear. Lenses shall bediscarded upon removal.
Type of use	Prescription Use	Prescription Use	Same
Single Use	Yes	Yes	Same
UV Blocking	Yes	Yes	Same
Production Method	Cast-Molded	Cast-Molded	Same
USAN Name	etafilcon A	etafilcon A	Same
Color additive	RB2461,4-Bis[4-(2-methacryloxyethyl)phenylamino] anthraquinonecopolymers	[Phthalocyaninato(2-)]copper	Different butRB246 is alsoapproved;therefore it wouldnot affect theequivalence
Base Curve	7.85 mm to 10.0 mm	7.85 mm to 10.0 mm	Same
Chord Diameter	12.0 mm to 15.00 mm	12.0 mm to 15.00 mm	Same
Center Thickness	Varies with power0.080 mm at -3.00D0.200 mm at +3.00D	0.01 mm to 0.20 mm	Different but thespecification meetsthe requirement;therefore it wouldnot affect theequivalence
Water Content (%)	58%	58%	Same
Refractive Index(hydrated)	1.400	1.400	Same
Item	Subject device	Predicate device	Substantialequivalencedetermination
Oxygen Permeability	$23.42 \times 10^{-11} (cm^2/sec) (ml O_2/ml-mmHg)$	$29.96 \times 10^{-11} (cm^2/sec) (ml O_2/ml-mmHg)$	Different but thespecification meetsthe requirement;therefore it wouldnot affect theequivalence
Power Range	+4.50D ~ +6.00D in 0.50D per step+4.00D ~ -6.00D in 0.25D per step-6.50D ~ -13.00D in 0.50D per step	+6.00D to -10.00D (in 0.25D steps)Cylinder: -0.75D to -2.50D (in 0.25D steps) Axis: 10° to 180° (in 10° steps) Add: +1.00D to +2.50D (in 0.50D steps)	Different but itwould not affectthe equivalence
Visible LightTransmittance	95±5%	>98%	Different but thespecification meetsthe requirement;therefore it wouldnot affect theequivalence
UV transmittance	at 280~~315 nm: Avg<5%at 316~~380 nm: Avg<30%	at 280~~315 nm: Avg<5%at 316~~380 nm: Avg<30%	Same

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

5.11 Similarity and Difference

The Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens has been compared with "Tangible Hydrogel with Tangible Polymer (etafilcon A) ASPHERIC Soft (Hydrophilic) Daily Disposable Contact Lens". The subject device has same intended use, principle of operation and similar

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Traditional 510(k), K182734.S007 Section 5 - 510(k) Summary

technological characteristics as the predicate device. Although there are some specifications that are different between two devices, the performance test has been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device. The subject device has undergone safety and performance tests, and the results complied with the test requests. Therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.

5.12 Conclusion

After analyzing non-clinical laboratory studies and safety testing data, it can be concluded that the Unicon Hydrogel (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens is substantially equivalent to the predicate device.

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.