Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity.

Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non- diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multi-focal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, and Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear. Eye care practitioners may prescribe the lens for daily disposable wear. The lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The lens designs include spherical, toric and multifocal lenses.
UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution with PEG.

AI/ML Overview

N/A

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

October 7, 2025

St. Shine Optical Co., Ltd.
Mina Lee
Project Manager, R&D Div.
4,5F No. 276-2, Sec. 1, Ta Tung Rd.,Hsi Chih Dist.
New Taipei City, 22146
Taiwan

Re: K250364

Trade/Device Name: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Regulation Number: 21 CFR 886.5925
Regulation Name: Soft (Hydrophilic) Contact Lens
Regulatory Class: Class II
Product Code: LPL, MVN
Dated: August 29, 2025
Received: August 29, 2025

Dear Mina Lee:

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 (the 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 available 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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K250364 - Mina Lee Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.

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K250364 - Mina Lee Page 3

See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J Angelo Green -S

J. Angelo Green Ph.D.,
Assistant Director
DHT1A: Division of Ophthalmic Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K250364

Device Name: Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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, gather and maintain 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:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary

K250364

1 Submitter Information:

Address: St. Shine Optical Co., Ltd.
4,5F No. 276-2, Sec. l, Ta Tung Rd. Hsi
Chih Dist., 22146, New Taipei City Taiwan
R.O.C.

Registration No.: 9617499
Contact Person: Mina Lee
Project Manager, R&D Div.
E-mail: s7034@stshine.com.tw
Telephone: 886-2-2641-7543#228
Fax: 886-8691-6776
Date Prepared: August 6, 2025

2 Device:

Common Name: Soft (Hydrophilic) Contact Lens

Trade/Proprietary Name:

Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Classification Name: Soft (Hydrophilic) Contact Lens (daily wear)
Device Classification: Class II (21 CFR 886.5925)
Product Code: LPL, MVN
Panel: Ophthalmic

3 Predicate Devices:

Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens – K240477

Page 6

4 Description of Devices:

Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens:

The lens designs include spherical, toric and multifocal lenses.
UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution with PEG.

5 Indication for Use:

Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, and Saview SH Optic

Page 7

38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear. Eye care practitioners may prescribe the lens for daily disposable wear. The lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

6 Comparison of technological characteristics with the predicate device

	Subject Device	Predicate Device
Device	Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens	Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K240477)
Intended Use	Sphere: Daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity.	Sphere: Daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity.
	Toric: Daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.	Toric: Daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Page 8

	Subject Device	Predicate Device
	Multifocal: Daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.	Multifocal: Daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.
Modality	Daily disposable	Daily disposable and frequent replacement wear
Material (Classification)	Group 5C (Silicone hydrogel: low water subgroup)	Group 5C (Silicone hydrogel: low water subgroup)
USAN Name	Senofilcon A	Senofilcon A
Indication for use	Myopia, hyperopia, presbyopia, astigmatism	Myopia, hyperopia, presbyopia, astigmatism
Water content	38%	38%
Visible light transmittance	≧90%	≧90%
UV transmittance	UVB <5% UVA<50%	UVB <5% UVA<50%
Dk(35℃) non-edge corrected	122 x 10⁻¹¹	122 x 10⁻¹¹
Dk(35℃) boundary layer and edge corrected	103 x 10⁻¹¹	103 x 10⁻¹¹
Power	+20.00 to -20.00D Cylinder power: -0.50 to -3.00D (for toric only) Continuous add power to +3.00D (for multifocal only)	+20.00 to -20.00D Cylinder power: -0.50 to -3.00D (for toric only) Continuous add power to +3.00D (for multifocal only)
Color	Tint: [Phthalocyaninato(2-)] copper	Tint: [Phthalocyaninato(2-)] copper
Refractive index	1.42	1.42
Method of manufacture	Moulded	Moulded
Packaging materials	PP (Polypropylene) blister and Aluminum foil	PP (Polypropylene) blister and Aluminum foil
Package storage saline solution	Saline solution with PEG	Saline solution

Page 9

7 Summary of Non-clinical Performance Data

All tests were performed to assess the properties and safety and effectiveness of the contact lens following the 1994 FDA Guidance Document for Daily Wear Contact Lenses. Biocompatibility tests were conducted in accordance with the GLP regulation (21 CFR Part 58). All other testing was conducted according to scientific methods. Non-Clinical testing performed includes:

Physicochemical Properties is by previously submitted application, under 510(k) K240477 which lens materials are identical with subject device:

Extractables
Finished Lens Parameters
Transmittance
Refractive Index
Water Content
Oxygen Permeability
Mechanical Properties (Modulus, Tensile strength, Elongation, Toughness)
Leachable Additives
Specific Gravity

Test results demonstrated that is identical complies with ISO 11981:2017, ISO 18369-2:2017, ISO 18369-3:2017, 18369-4:2017, FDA Guidance- Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses (2006/05) requirements.

For Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens with PEG packaging solution:

Contact angle

Sterilization validation and Shelf life for subject device:

Stability Test
Autoclave Validation
Report of Evaluation for the Sterilization Efficacy of BI Inside and Outside of the Package
Sterility Test Report
Bioburden test
Clean Environment Test Controls Report

Test results demonstrated that subject device complies with ISO 17665-1:2006, USP<71>, ISO 11737-1:2018, ISO 11737-2:2019, USP<61>, ISO 11987:2012, ISO 18369-1:2017, ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017, ISO 14644-1:2015, ISO 14644-3:2019, NEBB: 2009 requirements.

Biocompatibility:

For lens is identical by previously submitted application, under 510(k) K240477 which lens materials are identical with subject device:

Cytotoxicity (ISO 10993-5:2009)

Page 10

Ocular Irritation (ISO 10993-23:2021)
Acute Systemic Injection (ISO10993-11:2017)

For packaging solution:

In Vitro Cytotoxicity Tests (ISO 10993-5:2009, ISO 10993-12:2021, USP<87>:2024)
Ocular Irritation (ISO 10993-23:2021)
Oral Toxicity (FDA's 1997 Premarket Notification (510(k)) Guidance for Contact Lens Care Products)

For packaging material:

Polypropylene (base) blister:

Cytotoxicity (ISO 10993-5:2009)
Ocular Irritation (ISO 10993-23:2021)
Acute Systemic Injection (ISO10993-11:2017)

Aluminum laminate:

Cytotoxicity (ISO 10993-5:2009)
Ocular Irritation (ISO 10993-23:2021)
Acute Systemic Injection (ISO10993-11:2017)

The material of blister package comprises a base and a cover. The base material is homo PP (Polypropylene) and the cover is a laminate of Aluminum foil. Therefore, all packaging materials including the base and the cover are as identical to packaging materials by previously submitted application, under 510(k) K240477.

Page 11

The testing performed on Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens demonstrated that Shelf-Life testing has shown the lenses remain sterile and that lens properties do not change before the expiration. The device is biocompatibility in a safe and effective manner. Performance tests included conformance to specifications, functional, test results verify that the device performs as expected and are equivalent to the predicate device without creating additional risk to the user.

8 Summary of Clinical Performance Data

No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing. Safety and effectiveness of the Senofilcon A lens material is identical with K240477. Safety and effectiveness of packaging material is identical with K240477. Safety and effectiveness of package storage saline solution with PEG are proved by biocompatibility reports including In Vitro Cytotoxicity Tests, Ocular Irritation, Oral Toxicity.

9 Substantial Equivalence Conclusion:

The information submitted in the 510(k) establishes that the Saview SH Optic 38 UV lenses are identical with K240477 physicochemical properties and cytotoxicity, ocular irritation and acute Systemic Injection as subject devices and do not raise questions of safety and effectiveness and biocompatibility in safety. Shelf life testing has shown Saview SH Optic 38 UV lenses remain sterile and that lens properties do not change before the expiration date. Results of cytotoxicity, ocular irritation and oral Toxicity for packaging solution and packaging materials showed substantially equivalent to the predicate device in safety and biocompatibility The function of polyethylene glycol (PEG) in the packaging solution is increasing the lens surface hydrophilicity as a wetting agent. Therefore, the Saview SH Optic 38 UV, Saview SH Optic 38 UV toric,

Page 12

Saview SH Optic 38 UV multifocal (Senofilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.

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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.