Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

K242916 · Largan Medical Co., Ltd. · LPL · Feb 4, 2025 · Ophthalmic

Device Facts

• Record ID: K242916
• Device Name: Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens
• Applicant: Largan Medical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 4, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity. Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

Device Story

Hemispherical, aspherical, flexible soft contact lens; composed of Polymacon (HEMA/EGDMA copolymer) with 38% water content. Designed for daily wear to correct myopia/hyperopia and alter eye color. Features light blue visibility tint (Reactive Blue 247) and benzophenone UV-absorbing monomer. Manufactured via cast molding. Prescribed by eye care practitioners for single-use disposable or frequent/planned replacement wear. If frequent replacement, requires chemical disinfection. Provides refractive correction; enhances cosmetic appearance. Benefits patients by improving visual acuity and providing desired aesthetic eye color change.

Clinical Evidence

Bench testing only. Performance data included back vertex power, radius of curvature, diameter, thickness, pH, osmotic pressure, refractive index, transmittance, water content, oxygen permeability, extractables, mechanical properties, and leachability of color additives. Biocompatibility testing (ISO 10993-5, 10, 11) confirmed non-cytotoxic, non-irritating, and non-sensitizing properties.

Technological Characteristics

Material: Polymacon (HEMA/EGDMA copolymer); 38% water content. Design: Aspherical, hemispherical shell. Diameter: 13.0-15.0 mm; Base Curve: 8.0-9.0 mm; Power: +3.00 to -10.00 D. UV-absorbing monomer included. Color additives per 21 CFR 73/74. Manufacturing: Cast molded. Sterilization: Sterile package with buffered saline.

Indications for Use

Indicated for daily wear to enhance/alter eye color and/or correct refractive ametropia (myopia/hyperopia) in phakic or non-aphakic persons with non-diseased eyes and refractive astigmatism ≤ 1.00D.

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

• Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens (K182674)
• Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523)

Submission Summary (Full Text)

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February 04, 2025

Largan Medical Co., Ltd. Shih-Min Chen RA Specialist 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist Taichung, 40850 Taiwan

Re: K242916

Trade/Device Name: Largan U38 Color (Polymacon) Daily Wear 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: September 04, 2024 Received: December 26, 2024

Dear Shih-Min Chen:

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.

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).

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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 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-reportingcombination-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 Rue"). 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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

Submission Number (if known)

K242916

Device Name

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

Indications for Use (Describe)

The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequentl planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal. therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

The-Counter Use (21 CFR 801 Subpart C)

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Preparation Date: May 23, 2024 Updated Date: Jan 31, 2025

#### 1 Establishment Information:

| Name | Largan Medical Co. Ltd. |
|-----------|-------------------------------------------------------------------------------------------|
| Owner | Adam Lin |
| Title | CEO |
| Address | 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun<br>Dist., Taichung, 40850, Taiwan |
| Phone No. | 886-4-3600-0203 |
| Fax No. | 886-4-3601-0203 |
| E-mail | [e-mail] |

#### 2 Contact Person:

| Phone No. | 886-4-3600-0203 #20246 |
|--------------|------------------------------|
| Fax No. | 886-4-3601-0203 |
| Contact Name | Shih-min Chen |
| E-mail | [e-mail] |

#### 3 Device Identification:

| Proprietary Name | Largan U38 Color (Polymacon) Daily Wear Sof<br>(hydrophilic) Contact Lens |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Daily Wear,<br>(21 CFR 886.5925, Product Code LPL)<br>Lenses, Soft Contact, Daily Wear (Disposable),<br>(21 CFR 886.5925, Product Code MVN) |
| Classification | II |
| Regulation Number | CFR 886.5925 |
| Review Panel | Ophthalmic |
| Product Code | LPL; MVN |

#### 4 Predicate Device:

- 4.1 Legally Marketed Equivalent Device (Primary):

| Predicate Device Name | Largan U38 (Polymacon) Daily Wear Soft<br>(hydrophilic) Contact Lens |
|-----------------------|----------------------------------------------------------------------|
| Manufacturer | Largan Medical Co. Ltd. |
| 510(k) Number | K182674 |
| Product Code | LPL; MVN |

#### 4.2 Legally Marketed Equivalent Device (Secondary):

| Predicate Device Name | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens |
|-----------------------|-----------------------------------------------------------------------------|
| Manufacturer | Largan Medical Co. Ltd. |
| 510(k) Number | K182523 |
| Product Code | LPL; MVN |

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#### ഗ Device Description

The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia. The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Polymacon) is a hydrophilic co-polymer by crosslinking 2-Hydroxyethyl methacrylate (HEMA). and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 62.0% (Polymacon) and 38.0% water by weight of saline immersed in normal saline. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzophenone UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 315 to 380 nm. The lenses contain a combination of the following color additives: Phthalocyanine green, Carbazole violet, [Phthalocyaninato (2-)] copper, Titanium dioxide, Iron oxides (Red, Yellow and Black),and Mica-based pearlscent pigment (Gold, Silver and Red). All color additives used are listed in 21 CFR 73 subpart D and 74 subpart D. It is supplied in a sterile package with buffered saline solution.

#### 6 Indications for Use

The Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for daily wear to enhance or alter the apparent color of the eye and/or for the correction of refractive ametropia (myopia and hyperopia) in phakic or non-aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for either single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear, the lens is to be discarded after each removal, therefore no cleaning or disinfecting is required. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only.

#### 7 Technological characteristic

## Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

Characteristics:

- Diameter Range: 13.0 to 15.0 mm
- Base Curve: 8.0 to 9.0 mm .
- Center Thickness:0.100 mm for -3.00 D
- Power: +3.00 to -10.00 D

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#### Comparison table 8

| Item | Subject Device | Predicate (Primary) | Predicate (Secondary) |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Largan U38 Color<br>(Polymacon) Daily Wear<br>Soft (hydrophilic)<br>Contact Lens | Largan U38<br>(Polymacon) Daily Wear<br>Soft (hydrophilic)<br>Contact Lens | Largan 55 UV Color<br>(Ocufilcon D) Daily<br>Wear Soft (hydrophilic)<br>Contact Lens |
| K number | K242916 | K182674 | K182523 |
| Product code | LPL; MVN | LPL; MVN | LPL; MVN |
| Manufacturer | Largan Medical Co. Ltd. | Identical | Identical |
| Intended Use | Myopia, Hyperopia | Identical | Identical |
| Indication for<br>use | The Largan U38 Color<br>(Polymacon) Daily Wear<br>Soft (hydrophilic)<br>Contact Lens is a daily<br>wear soft contact lens<br>indicated for daily wear<br>to enhance or alter the<br>apparent color of the eye<br>and/or for the correction<br>of refractive ametropia<br>(myopia and hyperopia)<br>in phakic or non-aphakic<br>persons with non-<br>diseased eyes who<br>exhibit refractive<br>astigmatism of 1.00D or<br>less where the<br>astigmatism does not<br>interfere with visual<br>acuity.<br>Eye care practitioners<br>may prescribe the lens<br>for either single-use<br>disposable wear, or for<br>frequent/planned<br>replacement wear, with<br>cleaning, disinfection,<br>and scheduled<br>replacement. When<br>prescribed for single-<br>use disposable wear,<br>the lens is to be<br>discarded after each<br>removal, therefore no<br>cleaning or<br>disinfecting is required.<br>When prescribed for<br>frequent replacement,<br>the lens may be<br>disinfected using a<br>chemical disinfection<br>system only. | The Largan U38<br>(Polymacon) Daily<br>Wear Soft (hydrophilic)<br>Contact Lens is a daily<br>wear soft contact lens<br>indicated for the<br>correction of refractive<br>ametropia (myopia and<br>hyperopia) in phakic or<br>non-aphakic persons<br>with non-diseased eyes<br>who exhibit refractive<br>astigmatism of 1.00D or<br>less where the<br>astigmatism does not<br>interfere with visual<br>acuity.<br>Eye care practitioners<br>may prescribe the lens<br>for either single-use<br>disposable wear, or for<br>frequent/planned<br>replacement wear, with<br>cleaning, disinfection,<br>and scheduled<br>replacement. When<br>prescribed for single-use<br>disposable wear, the lens<br>is to be discarded after<br>each removal, therefore<br>no cleaning or<br>disinfecting is required.<br>When prescribed for<br>frequent replacement,<br>the lens may be<br>disinfected using a<br>chemical disinfection<br>system only. | The Largan 55 UV<br>Color (Ocufilcon D)<br>Daily Wear Soft<br>(hydrophilic) Contact<br>Lens is a daily wear soft<br>contact lens indicated for<br>the correction of<br>refractive ametropia<br>(myopia and hyperopia)<br>in phakic or non-aphakic<br>persons with non-<br>diseased eyes who<br>exhibit refractive<br>astigmatism of 1.00D or<br>less where the<br>astigmatism does not<br>interfere with visual<br>acuity.<br>Eye care practitioners<br>may prescribe the lens<br>for either single-use<br>disposable wear, or for<br>frequent/planned<br>replacement wear, with<br>cleaning, disinfection,<br>and scheduled<br>replacement. When<br>prescribed for single-use<br>disposable wear, the lens<br>is to be discarded after<br>each removal, therefore<br>no cleaning or<br>disinfecting is required.<br>When prescribed for<br>frequent replacement,<br>the lens may be<br>disinfected using a<br>chemical disinfection<br>system only. |
| Lens Design | Aspherical | Identical | Identical |
| Replacement<br>Schedule | Daily Wear/ frequent<br>replacement | Identical | Identical |
| Chemical<br>composition | Polymacon | Identical | Ocufilcon D |
| Classification | Group I (Nonionic, Low<br>water) | Identical | Group IV (Ionic, High<br>water) |
| Water<br>Content | 38% (<50%) | Identical | 55% |
| Oxygen<br>Permeability<br>(DK, 35°C ) | 8.0 (Fatt method) | Identical | 19.6 (Fatt method) |
| Base Curve<br>Range(mm) | 8.0~9.0 | Identical | Identical |
| Diameter<br>(mm) | 13.0~15.0 | Identical | Identical |
| Center<br>Thickness | Varies with design and<br>Power (0.100 mm at -<br>3.00D) | Identical | Identical |
| Powers | -10.00D to +3.00D | Identical | Identical |
| Refractive<br>Index | 1.435 | Identical | 1.405 |
| Light<br>Transmittance | 90% | Identical | Identical |
| Color additives | • Phthalocyanine green<br>• Carbazole violet<br>• [Phthalocyaninato(2-)]<br>copper<br>• Titanium dioxide<br>• Iron oxides<br>• Mica-based pearlscent<br>pigment | Reactive Blue 247 | • Phthalocyanine green<br>• Carbazole violet<br>• [Phthalocyaninato(2-)]<br>copper<br>• Titanium dioxide<br>• Iron oxides<br>• Chromium-cobalt-<br>aluminum oxide<br>• Mica-based pearlscent<br>pigment |
| Method of<br>Manufacture | Cast Molded | Identical | Identical |

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#### ல் Performance data

The following performance data were provided in support of the substantial equivalence determination.

#### 9.1 Non-Clinical Tests

The non-clinical tests had been performed to demonstrate the safety and effectiveness of Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens. Non-Clinical testing performed includes:

- Back Vertex Power ●
- Radius of Curvature
- Overall Diameter
- Center Thickness
- Inspection of Edges, Inclusions and Surface Imperfections
- pH values
- Osmotic Pressure
- . Refractive Index
- Transmittance
- Water content
- Oxygen permeability
- Extractables
- . Mechanical properties
- . Leachability of color additives

#### 9.2 Biocompatibility Test

The biocompatibility evaluation for the Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens was conducted in accordance with the FDA "Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses (1994)," as recognized by FDA. The packaging solution is identical to the predicate devices (K182674 and K182523). Additional testing of lens materials and primary packaging included:

- In-Vitro Cytotoxicity was performed on extracts of the finished contact lenses ● and the primary packaging in accordance with…