Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo

K202129 · Largan Medical Co., Ltd. · LPL · Apr 1, 2021 · Ophthalmic

Device Facts

• Record ID: K202129
• Device Name: Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo
• Applicant: Largan Medical Co., Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 1, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic 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. The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters 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. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.

Device Story

Hemispherical, flexible, hydrophilic soft contact lenses; made of Ocufilcon D copolymer cross-linked with EGDMA; 55% water content. Available as aspherical, toric, or multifocal designs. Used by patients for daily wear to correct refractive errors (myopia, hyperopia, astigmatism, presbyopia). Color variants provide cosmetic enhancement. Prescribed by eye care practitioners for single-use disposable or frequent replacement (up to 1 month). Lenses cover cornea and adjacent sclera; include UV-absorbing monomer and various colorants. Benefit: vision correction and cosmetic alteration.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing (physiochemical properties per ISO 18369-4) and biocompatibility testing (ISO 10993 series: cytotoxicity, ocular irritation, systemic toxicity).

Technological Characteristics

Material: Ocufilcon D (hydrophilic copolymer cross-linked with EGDMA). Water content: 55%. Oxygen permeability (Dk): 19.6 (Fatt method). Refractive index: 1.405. Manufacturing: Cast molded. UV-absorbing monomer included. Colorants: Phthalocyanine green, Carbazole violet, Copper phthalocyanine, Titanium dioxide, Iron oxides, Chromium-cobalt-aluminum oxide, Mica-based pearlescent pigment, Yellow 15. Packaging: Saline with sodium hyaluronate and poloxamer Kolliphor P407.

Indications for Use

Indicated for correction of refractive ametropia (myopia/hyperopia) in aphakic/non-aphakic persons with non-diseased eyes. Includes variants for astigmatism (-0.25 to -5.00D) and presbyopia (add powers +0.25 to +3.50D). Color variants enhance/alter eye color.

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 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K181232)
• Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 1, 2021

Largan Medical Co., Ltd. Amy Tien RA Specialist 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung, 40850 Taiwan

Re: K202129

Trade/Device Name: Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: February 25, 2021 Received: February 26, 2021

Dear Amy Tien:

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 (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 located 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.

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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.

For comprehensive regulatory information about medical devices and radiation-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.

for Angelo Green Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K202129

#### Device Name

Largan DB/ DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens Largan DB/ DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM Largan DB/ DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA

#### Indications for Use (Describe)

The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft (hydrophilic) contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic 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.

The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (ocuffilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of amercopia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.

The Largan DB (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopial Largan DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters 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 disinfection system only. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

## 510(k) Summary

Preparation Date: March 22, 2021

# 1.1 Establishment Information:

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

## 1.2 Contact Person:

| Phone No. | 886-4-3600-0203 |
|--------------|--------------------------|
| Fax No. | 886-4-3601-0203 |
| Contact Name | Amy Tien |
| E-mail | [e-mail] |

# 1.3 Device Identification:

| Proprietary Name | Largan DB (Ocufilcon D) Daily Wear Soft<br>(hydrophilic) Contact Lens; Largan DB Color<br>(Ocufilcon D) Daily Wear Soft (hydrophilic) Contact<br>Lens; Largan DB (Ocufilcon D) Daily Wear Soft<br>(hydrophilic) Contact Lens for Astigmatism; Largan<br>DB Color (Ocufilcon D) Daily Wear Soft<br>(hydrophilic) Contact Lens for Astigmatism; Largan<br>DB (Ocufilcon D) Daily Wear Soft Contact Lens for<br>Presbyopia; Largan DB Color (Ocufilcon D) Daily<br>Wear Soft (hydrophilic) Contact Lens for Presbyopia |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | CRF 886.5925 |
| Review Panel | Ophthalmic |
| Product Code | LPL;MVN |

{4}------------------------------------------------

## 1.4 Legally Marketed Equivalent Device:

| Predicate Device Name | Largan 55 UV (Ocufilcon D) Daily Wear Soft<br>(hydrophilic) Contact Lens; Largan 55 UV (Ocufilcon<br>D) Daily Wear Soft (hydrophilic) Contact Lens for<br>Astigmatism; Largan 55 UV (Ocufilcon D) Daily Wear |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Soft (hydrophilic) Contact Lens for Presbyopia/ |
| | Largan 55 UV Color(Ocufilcon D) Daily Wear Soft |
| | (hydrophilic) Contact Lens; Largan 55 UV |
| | Color(Ocufilcon D) Daily Wear Soft (hydrophilic) |
| | Contact Lens for Astigmatism; Largan 55 UV |
| | Color(Ocufilcon D) Daily Wear Soft (hydrophilic) |
| | Contact Lens for Presbyopia |
| Manufacturer | Largan Medical Co. Ltd. |
| 510(k) Number | K181232/ |
| | K182523 |
| Product Code | LPL; MVN |

### 1.5 Device Description

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available as an aspherical lens, multifocal lens and as an astigmatic (toric) lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer cross-linked with Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of immersed in normal saline

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA and Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA is a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera. UV absorbing monomer is used to filter UV radiation. Reactive Yellow 15 is used to tint the lens. The average transmittance characteristics (the thinnest lens measured by spectrophotometry as stated in ISO 18369) are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 315 to 380 nm. The lenses are available with a visibility-handling tint or with a decorative tint intended to enhance or alter the apparent color of the eye.

{5}------------------------------------------------

### 1.6 Indication for Use:

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a daily wear soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic 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.

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters.

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add powers from +0.25 to +3.50 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters 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. When prescribed for frequent replacement, it is recommended that the lenses be discarded and replaced with a new lens not more than every 1 month. However, the Eye Care Professional is encouraged to determine an appropriate replacement schedule based upon the response of the patient. The Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is also intended to enhance or alter the apparent color of the eye.

{6}------------------------------------------------

- 1.7 Technological characteristic
## Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens/ Largan DB Color (Ocufilcon D) 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:0.084 mm for -3.00D (varies with power) ●
- Power: +3.00 to -10.00 D ●

### Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism

characteristics:

- Diameter Range: 13.0 to 15.0 mm ●
- Base Curve:8.0 to 9.0 mm ●
- Center Thickness:0.084 mm for -3.00D (varies with power) .
- Power: +3.00 to -10.00 D ●
- . Cylinder: -0.25D ~ -5.00 D
- Axis: 10° to 180° (in 10°increments) .

# Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia

characteristics:

- Diameter Range: 13.0 to 15.0 mm ●
- Base Curve:8.0 to 9.0 mm .
- Center Thickness:0.130 mm for -3.00D (varies with power) .
- Power : +3.00 to -10.00 D
- Additional Powers: +0.25D ~ +3.50D ●

{7}------------------------------------------------

# 1.8 Comparison table:

The characteristic comparison to predicate devices is summarized in the following table.

| Similarities and differences | | | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Item | Device | Predicate (K181232) | Predicate (K182523) |
| Product Name | Largan DB (Ocufilcon D) Daily<br>Wear Soft (hydrophilic) Contact<br>Lens | Largan 55 UV (Ocufilcon<br>D) Daily Wear Soft<br>(hydrophilic) Contact Lens | Largan 55 UV Color<br>(Ocufilcon D) Daily Wear<br>Soft (hydrophilic) Contact Lens |
| Manufacturer | Largan Medical Co. Ltd. | The same | The same |
| Intended Use | Myopia, Hyperopia,<br>astigmatism, Presbyopia | The same | The same |
| Indication for use | The Largan DB (Ocufilcon D)<br>Daily Wear Soft (hydrophilic)<br>Contact Lens/ Largan DB Color<br>(Ocufilcon D) Daily Wear Soft<br>(hydrophilic) Contact Lens is a<br>daily wear soft contact lens<br>indicated for the correction of<br>refractive ametropia (myopia and<br>hyperopia) in phakic or non-aphakic<br>persons with non-diseased eyes who<br>exhibit refractive astigmatism of<br>1.00D or less where the astigmatism<br>does not interfere with visual acuity. | The same | The same |

{8}------------------------------------------------

The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism/ Largan DB Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters and astigmatic corrections are from -0.25 to -5.00 diopters. The Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia/ Largan DB Color(Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and nonaphakic persons with non-diseased eyes and whose powers are from -10.00 to +3.00 diopters with add

powers from +0.25 to +3.50

{9}------------------------------------------------

| diopters. The lenses may be worn by<br>persons who exhibit astigmatism of<br>1.00 diopters or less where the<br>astigmatism does not interfere with<br>visual acuity. | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Eye care practitioners may prescribe<br>the lens for either single-use<br>disposable wear, or for<br>frequent/planned replacement wear,<br>with cleaning, disinfection, and<br>scheduled replacement. When<br>prescribed for single-use disposable<br>wear, the lens is to be discarded<br>after each removal, therefore no<br>cleaning or disinfecting is required.<br>When prescribed for frequent<br>replacement, the lens may be<br>disinfected using a chemical<br>disinfection system only. When<br>prescribed for frequent replacement,<br>it is recommended that the lenses be<br>discarded and replaced with a new<br>lens not more than every 1 month.<br>However, the Eye Care Professional<br>is encouraged to determine an<br>appropriate replacement schedule<br>based upon response of the patient. | |

{10}------------------------------------------------

| | The Largan DB Color (Ocufilcon<br>D) Daily Wear Soft (hydrophilic)<br>Contact Lens is also intended to<br>enhance or alter the apparent color<br>of the eye. | | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lens Design | Aspherical, toric, or<br>multifocal | The same | The same |
| Replacement Schedule | Daily Wear | The same | The same |
| Chemical composition | Ocufilcon D | The same | The same |
| Classification | Group IV (Ionic, High water) | The same | The same |
| Water Content | 55 % | The same | The same |
| Oxygen Permeability<br>(DK, 35°C ) | 19.6<br>(Fatt method) | The same | The same |
| Base Curve Range(mm) | 8.0~9.0 | The same | The same |
| Diameter (mm) | 13.0~15.0 | The same | The same |
| Center Thickness | Varies with power | The same | The same |
| Powers | -10.00D to +3.00D | The same | The same |
| Refractive Index | 1.405 | The same | The same |
| Light Transmittance | 90% | The same | The same |
| Color additives | ● Phthalocyanine green<br>● Carbazole violet<br>● [Phthalocyaninato(2-)]copper<br>● Titanium dioxide<br>● Iron oxides<br>● Chromium-cobaltaluminum<br>oxide<br>● Mica-based pearlscent pigment<br>● Yellow 15 | ● Reactive Blue 246 | ● Phthalocyanine green<br>● Carbazole violet<br>● [Phthalocyaninato(2-)]copper<br>● Titanium dioxide<br>● Iron oxides<br>● Chromium-cobaltaluminum<br>oxide<br>● Mica-based pearlscent<br>pigment |
| Method of<br>Manufacture | Cast Molded | The same | The same |
| Packaging saline | Saline solution with sodium<br>hyaluronate and poloxamer<br>kolliphor P407 | The same | The same |

{11}------------------------------------------------

## 1.9 Nonclinical Tests Performed

- 1.9.1 Physiochemical studies were conducted according to ISO 18369-4 second edition 2017-08, Ophthalmic optics -Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specification for the lenses.
- 1.9.2 Biocompatibility studies including cytotoxicity, acute ocular irritation, and acute systemic injection toxicity studies of subject lenses and primary package (polypropylene blister and aluminum foil) were conducted according to ISO 10993 series biocompatibility standard to assess the biological safety of the medical device and all of them are nontoxic and biocompatible. Biocompatibility tests following referenced standards as below:
- ISO 10993 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity. (2009) 1.
- 2. ISO 10993 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization. (2010)
- ISO 10993 Biological evaluation of medical devices- Part 11: Tests for Systemic toxicity. (2006) 3.
- 4. ISO 10993 Biological evaluation of medical devices- Part 12: Sample preparation and reference materials. (2012)

{12}------------------------------------------------

### 1.10 Clinical Studies

The technical characteristics, formulation, manufacturing process of the subject device are equivalent to Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K181232) and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K182523) current marketed by Largan Medical Co., Ltd, therefore no clinical data is required.

## 1.11 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "Largan DB (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens" demonstrates substantial equivalence as the predicate device.