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

K252385 · Pegavision Corporation · LPL · Mar 13, 2026 · Ophthalmic

Device Facts

• Record ID: K252385
• Device Name: Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses
• Applicant: Pegavision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Mar 13, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

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. 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. 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. 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.

Device Story

Soft hydrophilic contact lenses; Toufilcon B copolymer material; available in spherical, aspherical, toric, and multifocal designs; includes UV blocker. Input: patient refractive error; Output: vision correction. Used by patients for daily wear; prescribed by eye care professionals. Lenses manufactured via cast-molding; sterilized via moist heat. Packaged in borate-buffered saline solution containing Tween 80, Polyethylene Glycol, Sodium Hyaluronate, and optionally Cyanocobalamin. Benefits include refractive error correction and UV protection.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by identical material and manufacturing process to predicate K243868. Non-clinical bench testing performed per ISO 18369-3/4 and ISO 10993 series (cytotoxicity, ocular irritation, systemic toxicity, skin sensitization) demonstrated safety and effectiveness.

Technological Characteristics

Material: Toufilcon B (2-HEMA, NVP, DMA, MAA, SiGMA, PDMS macromer); 50% water content. Oxygen permeability: 91 x 10^-11. UV blocking: 95% UVB, 50% UVA. Sterilization: Moist heat. Manufacturing: Cast-molding. Packaging: Borate-buffered saline with additives. Standards: ISO 18369 (optical/physical), ISO 10993 (biocompatibility), ISO 11987 (shelf life/sterility).

Indications for Use

Indicated for daily wear vision correction of myopia, hyperopia, and/or presbyopia in aphakic or non-aphakic persons with non-diseased eyes; includes astigmatism correction up to 2.00D (spherical/multifocal) or -0.25D to -3.50D (toric).

Regulatory Classification

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.

Predicate Devices

• Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses (K243868)

Reference Devices

• Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (K232649)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 13, 2026

Pegavision Corporation
Estela Lin
Regulatory Affair Engineer Supervisor
2F-1, No. 5, Shing Yeh St., Guishan Dist.
Taoyuan City, 33341
Taiwan

Re: K252385
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: July 31, 2025
Received: February 2, 2026

Dear Estela Lin:

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

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K252385 - Estela Lin
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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.

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K252385 - Estela Lin
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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 ([e-mail]) or phone [phone] 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

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| 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. | K252385 | ? |
| 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. | | |
| 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 (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |

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K252385

# 510(k) SUMMARY

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: | Estela Lin, Regulatory Affair Engineer Supervisor |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| E-Mail: | [e-mail] |
| Date Prepared: | July 31, 2025 |

## 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, and multifocal designs. The lens material, Toufilcon B is a co-polymer of 2-Hydroxyethylmethacrylate

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(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 photopolymerization. The copolymer consists of 50% Toufilcon B and 50% water by weight when immersed in a borate-buffered saline solution. There are two types of buffer solutions: one contains Tween 80, Polyethylene Glycol, and Sodium Hyaluronate; the other contains the same components with the addition of Cyanocobalamin. 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.

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- 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.

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.

| Device Name/ Subgroups | Subject Device | Predicate Device |
| --- | --- | --- |
| | PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses | PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses |
| | PEGAVISION (Toufilcon B) Daily Disposable 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 |

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| Device Name/Subgroups | Subject Device | Predicate Device |
| --- | --- | --- |
| | PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses | PEGAVISION (Toufilcon B) Soft (Hydrophilic) Contact Lenses |
| | PEGAVISION (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses | PEGAVISION (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses |
| Intended use | Spherical and Aspherical, Toric, Multifocal | 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 with Tween 80, Polyethylene Glycol and Sodium Hyaluronate● Borate buffer saline with Tween 80, Polyethylene Glycol, Sodium Hyaluronate and Cyanocobalamin | 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(cm2/s) [mlO2/(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 |

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# Summary of Clinical Study

The Toufilcon B material has already undergone clinical evaluation, as demonstrated in 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.

# Non-clinical Study

All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses. The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses.

Non-Clinical testing performed includes:

- Physicochemical Properties
- Refractive Index (ISO 18369-4)
- Water content (ISO 18369-4)
- Extractable (ISO 18369-4)
- Visible & UV Light Transmittance (ISO 18369-3)
- Shelf Life Test and Sterility Test (ISO 11987)
- Dynamic Contact Angle

The results demonstrated that the lens met all established specifications and requirements for physical, optical, and chemical properties.

- Biocompatibility Test

The biocompatibility evaluation of this product was conducted in accordance with the ISO 10993 series standards for the biological evaluation of medical devices. The evaluation included relevant tests for both the contact lens materials and the packaging components:

| Contact Lenses (Toufilcon B) |
| --- |
| • Cytotoxicity Test (ISO 10993-5) |
| • Ocular Irritation Test (ISO 10993-23) |

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| • Acute Systemic Toxicity Test (ISO 10993-11)
• Skin Sensitization Study (Maximization Test) (ISO 10993-10) |
| --- |
| Packaging Solution |
| • Cytotoxicity Test (ISO 10993-5)
• Ocular Irritation Test (ISO 10993-10)
• Skin Sensitization Study (Maximization Test) (ISO 10993-10) |
| PP blister and aluminum foil (identical to K232649) |
| • Cytotoxicity Test (ISO 10993-5)
• Ocular Irritation Test (ISO 10993-10)
• Acute Systemic Toxicity Test (ISO 10993-11) |

Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses use the same primary packaging materials as the K232649 Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses. The raw materials and formulation of the primary packaging materials (Aluminum Foil 4-Layer and PP blister) are identical. The safety of the these materials has been verified through biocompatibility testing performed for the referenced device (K232649) in accordance with the ISO 10993 series of standards; therefore, additional testing for primary packaging was not required.

The test results demonstrated that the contact lens exhibit no cytotoxicity, no ocular irritation, no skin sensitization, and no acute systemic toxicity. All biocompatibility tests yielded passing results, confirming that the product does not contain any toxic or harmful substances that may pose a risk to biological systems.

## Substantial Equivalence Statement

The technological characteristics of the subject device—including lens design, base curve, diameter, center thickness, lens material (Toufilcon B), water content, oxygen permeability, and sterilization method—are identical to those of the predicate device (K243868).

The only difference lies in the chemical composition of the packaging solution. Biocompatibility testing for subject lens and the packaging solution has demonstrated that the subject device does not adversely affect safety or performance.

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Therefore, the Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses are considered substantially equivalent to the predicate device, K243868.

## 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.

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