Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses

{0} FDA U.S. FOOD & DRUG ADMINISTRATION May 19, 2026 Pegavision Corporation Maggie Hong Regulatory Affair Senior Engineer 2f-1, #5, Shing Yeh St., Guishan Dist. Taoyuan City, 33341 Taiwan Re: K261299 Trade/Device Name: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 17, 2026 Received: April 20, 2026 Dear Maggie Hong: 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} K261299 - Maggie Hong 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. 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} K261299 - Maggie Hong 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 {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. | K261299 | ? | | --- | --- | --- | | Please provide the device trade name(s). | | ? | | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | | | | Please provide your Indications for Use below. | | ? | | Sphere/Asphere Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D. | | | | Toric Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D. | | | | Multifocal Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition of +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. | | | | Multifocal-Toric Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition of +0.25D to +3.00D and have -3.50 diopters of astigmatism or less. | | | | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. | | | | 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} 510(k) SUMMARY K261299 The following 510(K) Summary is being submitted as required by 21CFR 807.92(a). ## Submitter Information | Company: | PEGAVISION CORPORATION 2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333, Taiwan | | --- | --- | | Contact Person: | Maggie Hong, Regulatory Affair Senior Engineer | | Phone: | 886-3-329-8808 | | Fax: | 886-3-329-8897 | | E-Mail: | MaggieHong@pegavision.com | | Date Prepared: | April 20, 2026 | ## Identification of Device | Trade Name: | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | | --- | --- | | Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) | | Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925, Product Code LPL Lens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN | | FDA Classification: | Class II | | Predicate Device: | K243868, Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | ## Description of Device Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are clear or visibility tinted, incorporate a UV blocker, and are available in spherical, aspherical, toric, multifocal and multifocal-toric designs. The lens material, Toufilcon B is a co-polymer of 2- Page 1 of 6 {5} Hydroxyethylmethacrylate (2-HEMA), N-Vinyl-2-Pyrrolidinone (NVP), N,N-Dimethylcarylamide (DMA), Methacrylic Acid (MAA), (3-Methacryloxy-2-hydroxypropoxy)propyl-bis(trimethylsiloxy)methylsilane (SiGMA) and Polydimethylsiloxane macromer (monofunctional Polydimethylsiloxane) (PDMS macromer), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and Triallyl isocyanurate (TAIC) via photo-polymerization. The copolymer consists of 50% Toufilcon B and 50% water by weight when immersed in a borate-buffered saline solution. The visibility tinted lens is tinted with Reactive Blue 19, 21 CFR 73.3121. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Toufilcon B name has been adopted by the United States Adopted Names Council (USAN). ## Indications for use ### Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses #### Sphere and Asphere Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D. #### Toric Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Toric designs are indicated for daily wear for vision correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical powers ranging from +6.00D to -12.00D and astigmatic corrections from -0.25D to -3.50D. #### Multifocal Page 2 of 6 {6} Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition of +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. ## Multifocal-Toric Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses with Multifocal-Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition of +0.25D to +3.00D and have -3.50 diopters of astigmatism or less. Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses are intended for single-use disposable wear. Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are intended for frequent/planned replacement wear with cleaning, rinsing, disinfecting and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. ## Technological characteristics studies The technological characteristics of the Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses, as compared to the predicate devices, are summarized in the following table. Page 3 of 6 {7} | Device Name/Subgroups | Subject Device | Predicate Device | | --- | --- | --- | | | PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses PEGAVISION (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses | PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses PEGAVISION (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses | | 510(k) Number | New Device | K243868 | | USAN name | Toufilcon B | Toufilcon B | | FDA Category (Group) | Group 5 | Group 5 | | Intended use | Spherical and Aspherical, Toric, Multifocal, Multifocal-Toric | Spherical and Aspherical, Toric, Multifocal | | Expected clinical performance | Eye for vision correction | Eye for vision correction | | Indications | Daily wear | Daily wear | | Replacement schedule | Daily/Bi-weekly/Monthly | Daily/Bi-weekly/Monthly | | Production Method | Cast-molding | Cast-molding | | Sterilization Method | Moist Heat | Moist Heat | | Packaging Solution | Borate buffer saline | Borate buffer saline | | Lens color | Clear or Visibility tinted | Clear or Visibility tinted | | UV-blocking | Class II | Class II | | Water Content | 50%±2% | 50%±2% | | Oxygen Permeability x10^{-11} (cm^{2}/s) [ mlO_{2}/(ml × mmHg) ] | 91 | 91 | | Light Transmittance | 95±5% | 95±5% | | Powers | +6.00D ~ -12.25D | +6.00D ~ -12.25D | | Cylinder Power | -0.25D ~ -3.50D | -0.25D ~ -3.50D | | ADD Power | +0.25D ~ +3.00D | +0.25D ~ +3.00D | | Refractive Index | 1.405 | 1.405 | ## Summary of Clinical Study The Toufilcon B material has already undergone clinical evaluation, as demonstrated in {8} the FDA-cleared K243868, submitted by PEGAVISION Corporation for the Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses. As the material and manufacturing process used in the subject device are identical to those of the predicate device (K243868), no additional clinical data are required to support this 510(k) premarket notification. ## Summary of Non-clinical Study The technological characteristics of the subject device—including lens design, base curve, diameter, center thickness, lens material (Toufilcon B), packaging solution, water content, oxygen permeability, and method of sterilization—are identical to those of the predicate device (K243868). The only difference is the addition of a Multifocal-Toric optical design. Verification and validation testing were conducted to evaluate lens geometric parameters (diameter, base curve, and center thickness) and optical properties (power, cylinder, and add power) for the modified Multifocal-Toric design. The results demonstrate that the subject device meets established acceptance criteria and performs as intended. This modification is limited to the optical geometry and does not affect the material composition, manufacturing process, or mode of action of the device. Biocompatibility and other non-clinical testing (e.g., physicochemical, mechanical, and packaging/sterilization performance) were not repeated, as the subject device utilizes the same material, formulation, patient-contacting components, and is otherwise identical to the predicate device (K243868) in these aspects. Therefore, the previously established biocompatibility and non-clinical test reports and data from the predicate device (K243868) remain applicable. ## Substantial Equivalence Statement The technological characteristics of the subject device—including lens design, base curve, diameter, center thickness, lens material (Toufilcon B), Packaging Solution, water content, oxygen permeability, and method of sterilization—identical to the predicate device (K243868). The only difference is the addition of a Multifocal-Toric optical design. This modification is limited to optical geometry and does not affect the material composition, manufacturing process, or mode of action. Verification and validation testing, including optical performance evaluations, demonstrate that the subject device meets established acceptance criteria and performs as intended. The lens parameters (power, cylinder, add, center thickness, diameter, and base curve) are substantially equivalent to those of the predicate device. The proposed parameter ranges fall within Page 5 of 6 {9} those of the predicate, and no parameters exceed previously cleared ranges for the same material. Biocompatibility testing was not repeated, as the subject device utilizes the same material, formulation, and patient-contacting components as the predicate device. Therefore, previously established biocompatibility data remain applicable. Therefore, the subject device is considered to have equivalent technological characteristics and raises no new questions of safety or effectiveness compared to the predicate device. ## Conclusion A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices. Page 6 of 6