Miru 1day UpSide (midafilcon A)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 17, 2026 Menicon Co, Ltd. Bret Andre Consultant Andre Vision and Device Research 3762 Landis St. West Linn, OR 97068 Re: K262495 Trade/Device Name: Miru 1day UpSide (midafilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: June 29, 2026 Received: July 20, 2026 Dear Bret Andre: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262495 - Bret Andre 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 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (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 ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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. {2} K262495 - Bret Andre Page 3 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. 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 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 {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. | K262495 | ? | | Please provide the device trade name(s). | | ? | | Miru 1day UpSide (midafilcon A) | | | | Please provide your Indications for Use below. | | ? | | The Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism.The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism.The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism.The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses. The lenses should not be cleaned or disinfected and should be discarded after a single use. | | | | 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) | ? | | Please select the age group(s) for which the device(s) is to be used. | Neonates/Newborns (Birth to < 29 days old)Infants (29 days old to < 2 years old)Children (2 years old to < 12 years old)Adolescents (12 years old to < 22 years old)Adults (22 years old and greater) | ? | {4} Page 1 of 4 # 510 (k) SUMMARY This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. **The assigned 510(k) number is: K262495** ## I. SUBMITTER Date Prepared: June 29, 2026 Name: **Menicon Co., Ltd.** Address: 21-19, Aoi 3, Naka-ku, Nagoya, Aichi 460-0006 JAPAN Contact Person: Kana Nagasaki Regulatory Affairs Phone number: 81-52-9351676 Consultant: Bret Andre Andre Vision and Device Research 3762 Landis St West Linn, OR 97068 Phone number: (503) 372-5226 ## II. DEVICE Trade Name: Miru 1day UpSide (midafilcon A) Classification Name: 21 CFR § 886.5925 - Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Reason for Submission: Surface Treatment Change {5} Page 2 of 4 ### III. PREDICATE DEVICE The Miru 1day UpSide (midafilcon A) daily disposable soft contact lens is substantially equivalent in terms of actions, indications, and technological characteristics to the following predicate device: - “Miru 1day UpSide (midafilcon A)” By Menicon Co., Ltd. 510(k) number: K193399 Device Classification: II Product Code: LPL, MVN ### IV. DEVICE DESCRIPTION The Miru 1day UpSide (midafilcon A) daily disposable soft contact lens is a hydrophilic contact lens which is available as a spherical, toric and multifocal lens. The lens is indicated for daily wear disposable single use. The non-ionic lens material (midafilcon A) is a random co-polymer containing polydimethylsiloxane macromonomer. It consists of 44% midafilcon A and 56% water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility handling tint. The lens contains a benzotriazole UV absorbing monomer which is used to block UV radiation. The transmittance characteristics for the lens (-3.00D) are less than 5% of UVB radiation and less than 50% of UVA radiation. ### V. INDICATIONS FOR USE The Miru 1day UpSide (midafilcon A) SPHERICAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic people with disease free eyes who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) TORIC Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic people with disease free eyes with 3.00 diopter (D) or less of refractive astigmatism. The Miru 1day UpSide (midafilcon A) MULTIFOCAL Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic people with disease free eyes who may require a reading addition of 3.00 diopter (D) or less and who may have 1.50 diopter (D) or less of astigmatism. The Miru 1day UpSide (midafilcon A) should only be worn once and then discarded at the end of each wearing period on a daily basis. The patient should start the next wearing period with fresh lenses. The lenses should not be cleaned or disinfected and should be discarded after a single use. {6} Page 3 of 4 ## VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE The purpose of this 510(k) application is to add optional low-pressure plasma surface treatments with N₂ gas or with CO₂ gas in addition to the currently-510(k)-cleared atmospheric plasma. No other changes have been made; other than the surface treatment all other aspects of the Miru 1day UpSide (midafilcon A) daily disposable contact lens remain identical to the predicate device (K191872). The following matrix illustrates the intended use and other characteristics of the Miru 1day UpSide Daily Disposable Soft Contact Lens, as well as the predicate device. Table 1. Comparison table of the subject device with the predicate device | | Miru 1day UpSide (midafilcon A) | Miru 1day UpSide (midafilcon A) (K193399) | | --- | --- | --- | | 510(k) Number | New | K193399 | | USAN | Midafilcon A | Midafilcon A | | Product code | LPL, MVN | LPL, MVN | | Intended use | Daily wear, single use, contact lens for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia | Daily wear, single use, contact lens for the correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia | | Lens Designs | Spherical Toric Multifocal | Spherical Toric Multifocal | | FDA Lens Group | SiHy Group 5 | SiHy Group 5 | | Oxygen permeability ×10⁻¹¹ [(cm²/sec)=(mLO₂)(mL·mmHg)] | 64 | 64 | | Water content@23°C* | 56% | 56% | | Refractive index(n²ₑ₀) | 1.403 | 1.403 | | Specific gravity | 1.06 | 1.06 | | Light transmittance [%] | > 92% | >92% | | UV transmittance [%] | UV-A (315 to 380 nm): less than 50.0% UV-B (280 to 315 nm): less than 5.0% | UV-A (315 to 380 nm): less than 50.0% UV-B (280 to 315 nm): less than 5.0% | | Powers | - 20.00 to +20.00 D | - 20.00 to +20.00 D | | Diameter | 13.0 to 18.0mm | 13.0 to 18.0mm | | Base Curve | 8.0 to 9.0 mm | 8.0 to 9.0 mm | | Surface treatment | Low-pressure plasma with N₂ gas, or CO₂ gas, or atmospheric plasma | Atmospheric plasma | *Note: the water content of the Midafilcon A material was updated from 54% to 56% through USAN. ## VII. PERFORMANCE DATA ~ Non-Clinical Studies ~ A series of studies were completed to demonstrate the substantial equivalence of the Miru 1day {7} Page 4 of 4 UpSide (midafilcon A) daily disposable soft contact lens to the predicate device. Bulk property testing, biocompatibility, solution compatibility, preservative uptake release, extraction testing, and stability/shelf life testing were addressed in K193399 and are applicable to the subject device. Results of non-clinical testing on the modified device are summarized below: # Biocompatibility The midafilcon A contact lens in its final finished form is identical to the Miru 1day UpSide Daily Disposable Soft Contact Lens (cleared under K193399) with regards to formulation, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). Since the change in plasma treatment condition (atmospheric to low-pressure, change in gas with which is treated as low-pressure plasma) only affects the limited surface layer of the contact lenses, the biocompatibility tests which use extracts from the contact lenses may be referenced from the predicate device 510(k) submission for Miru 1 day UpSide (K193399). The applicable biocompatibility test that may be affected by surface condition is Cytotoxicity per ISO 10993-5. Cytotoxicity testing on the finished lenses using the direct contact method per ISO 10993-5 was conducted in accordance with Good Laboratory Practices (GLP) and the results confirmed the extracts are non-cytotoxic. Biocompatibility testing for the primary packaging solution and primary packaging is being leveraged from K193399 since these components are identical. # Contact Angle Testing Contact angle testing was performed on the subject device to evaluate the effect of the surface treatment. Testing was conducted according to ANSI Z80.20-2016. ~ Clinical Studies ~ Clinical studies were unnecessary for this application. # VIII. CONCLUSIONS # Substantial Equivalence Based on the results of the testing presented in this Premarket Notification, Miru 1day UpSide (midafilcon A) daily disposable soft contact lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.