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

{0} FDA U.S. FOOD &amp; DRUG ADMINISTRATION March 19, 2026 St. Shine Optical Co., Ltd. Lee Mina Project Manager, R&amp;D Div. 4,5f # 276-2, Sec. 1, Ta Tung Rd., Hsi Chih Dist. New Taipei City, 22146 Taiwan Re: K254269 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: December 18, 2025 Received: December 30, 2025 Dear Lee Mina: 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. U.S. Food &amp; Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254269 - Lee Mina 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 Management System Regulation (QMSR) (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. {2} K254269 - Lee Mina 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 {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254269 | ? | | Please provide the device trade name(s). | | ? | | 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 | | | | Please provide your Indications for Use below. | | ? | | 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 for frequent replacement wear. Eye care practitioners may prescribe the lens for frequent replacement wear. For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included). | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K254269 ## 5.1 Submitter Information: Address: St. Shine Optical Co., Ltd. 4,5F No. 276-2, Sec. 1, Ta Tung Rd. Hsi Chih Dist., 22146, New Taipei City Taiwan R.O.C. Registration No.: 9617499 Contact Person: Mina Lee Project Manager, R&amp;D Div. E-mail: s7034@stshine.com.tw Telephone: Telephone: 886-2-2641-7543#228 Fax: 886-8691-6776 Date Prepared: February 25, 2026 ## 5.2 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 ## 5.3 Predicate Devices: - Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, Saview Optic SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (for daily disposable wear) – K250364 ## 5.4 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. {5} K254269 - 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. ## 5.5 Indication for Use: 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 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 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is for frequent replacement wear. Eye care practitioners may prescribe the lens for frequent replacement wear. For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included). ## 5.6 Comparison of technological characteristics with the predicate device {6} K254269 | | 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 Optic 38 UV, Saview SH Optic 38 UV toric, Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens (K250364) | | 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. | | | 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 | Frequent replacement wear | Daily disposable wear | | Material (Classification) | Group 5C (Silicone hydrogel: low | Group 5C (Silicone hydrogel: low | {7} K254269 | | water subgroup) | water subgroup) | | --- | --- | --- | | USAN Name | Senofilcon A | Senofilcon A | | Indication for use | Myopia, hyperopia, presbyopia, astigmatism | Myopia, hyperopia, presbyopia, astigmatisn | | Water content | 38% | 38% | | Visible light transmittance | ≥90% | ≥90% | | UV transmittance | UVB <5% UVA <50% | UVB <5% UVA <50% | | Dk(35°C) non-edge corrected | 122 x 10-11 | 122 x 10-11 | | Dk(35°C) 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 with PEG | ## 5.7 Summary of Non-clinical Performance Data Tests to assess the properties, safety and effectiveness of the contact lens followed the recommendations in the 1994 FDA Guidance Document for Daily Wear Contact Lenses. Biocompatibility tests were conducted in accordance with {8} K254269 the GLP regulation (21 CFR Part 58). All other testing was conducted according to scientific methods. Non-Clinical testing performed includes: The lens material senofilcon A is identical to the material cleared in K250364. All physical properties were referenced to K250364: - Extractables - Finished Lens Parameters - Transmittance - Refractive Index - Water Content - Oxygen Permeability - Mechanical Properties (Modulus, Tensile strength, Elongation, Toughness) - Leachable Additives - Specific Gravity - Contact angle All tests comply 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 Applied Nutrition for Color Additives Used in or on Contact Lenses (2006/05) requirements. Lenses passed 30-cycle compatibility tests with representative care products. Sterilization validation and shelf-life were referenced to K250364 since this did not change. - Stability Test - Autoclave Validation - Report of Evaluation for the Sterilization Efficacy of BI Inside and Outside of the Package - Sterility Test Report 5 {9} K254269 - Bioburden test - Clean Environment Test Controls Report Test results demonstrated that subject device complies with ISO 17665-1:2006, USP&lt;71&gt;, ISO 11737-1:2018, ISO 11737-2:2019, USP&lt;61&gt;, 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: Biocompatibility did not change and is referenced to K250364. The following tests were previously completed: - Cytotoxicity (ISO 10993-5:2009) - Ocular Irritation (ISO 10993-23:2021) - Acute Systemic Injection (ISO10993-11:2017) The package solution did not change and is referenced to K250364. The following tests were completed: - In Vitro Cytotoxicity Tests (ISO 10993-5:2009, ISO 10993-12:2021, USP&lt;87&gt;: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 did not change and is referenced to K250364. The following tests were completed: Polypropylene (base) blister: - Cytotoxicity (ISO 10993-5:2009) - Ocular Irritation (ISO 10993-23:2021) - Acute Systemic Injection (ISO10993-11:2017) {10} K254269 Aluminum laminate: - Cytotoxicity (ISO 10993-5:2009) - Ocular Irritation (ISO 10993-23:2021) - Acute Systemic Injection (ISO10993-11:2017) The blister package is made from polypropylene with a laminate of aluminum foil. This package is identical to what was cleared in K250364. The Saview SH 38 UV (senofilcon A) Visibility Tinted Contact Lenses for frequent replacement passed 30-cycle compatibility tests. Therefore, the label modifications to include frequent replacement will not affect the safety and effectiveness of the device. The device is equivalent to the device cleared in K250364. ## 5.8 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 and packaging solution and packaging materials are identical with K250364, previously submitted application, under 510(k) K250364. Proposed Labeling and Test Report of Physical Compatibility of Contact Lens Care Products with Contact Lenses after Thirty Cycles for frequent replacement wear (subject devices). ## 5.9 Substantial Equivalence Conclusion: The information submitted in the 510k demonstrated that the Saview SH Optic 38 UV Lenses with frequent replacement are substantially equivalent to the Saview SH Optic 38 UV Daily Disposable Lenses in K250364.