(133 days)
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.
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.
This document describes the premarket notification (510(k)) clearance for the Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens. However, it does not contain information typically associated with acceptance criteria and a study that proves a device meets them in the context of an AI/ML medical device.
This type of FDA clearance (510(k)) is for a physical medical device (a contact lens) and relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study with quantifiable performance metrics against specific acceptance criteria for an algorithm.
Therefore, many of the requested elements for an AI/ML device (like sample size for test/training sets, ground truth establishment methods, expert qualifications, MRMC studies, or standalone performance) are not applicable or not provided in this document.
Here's the breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document provides a comparative table (Table 8) against predicate devices, focusing on physical and chemical characteristics. It does not present a formal "acceptance criteria" table with reported performance in the way one would for an AI/ML algorithm. Instead, it demonstrates similarity to predicate devices.
| Item | Acceptance Criteria (Implicit: Similar to Predicate) | Reported Device Performance (Largan U38 Color) |
|---|---|---|
| Product Name | Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens |
| K number | K182674 (Primary Predicate) | K242916 |
| Product code | LPL; MVN | LPL; MVN |
| Manufacturer | Largan Medical Co. Ltd. | Largan Medical Co. Ltd. |
| Intended Use | Myopia, Hyperopia | Myopia, Hyperopia |
| Indications for Use | Specific to "U38 Color" (enhances/alters color, plus correction of refractive ametropia <= 1.00D astigmatism, daily/frequent replacement) | Specific to "U38 Color" (enhances/alters color, plus correction of refractive ametropia <= 1.00D astigmatism, daily/frequent replacement) |
| Lens Design | Aspherical | Aspherical |
| Replacement Schedule | Daily Wear/frequent replacement | Daily Wear/frequent replacement |
| Chemical composition | Polymacon | Polymacon |
| Classification | Group I (Nonionic, Low water) | Group I (Nonionic, Low water) |
| Water Content | 38% (<50%) | 38% (<50%) |
| Oxygen Permeability (DK, 35°C) | 8.0 (Fatt method) | 8.0 (Fatt method) |
| Base Curve Range(mm) | 8.0~9.0 | 8.0~9.0 |
| Diameter (mm) | 13.0~15.0 | 13.0~15.0 |
| Center Thickness | Varies with design and Power (0.100 mm at -3.00D) | Varies with design and Power (0.100 mm at -3.00D) |
| Powers | -10.00D to +3.00D | -10.00D to +3.00D |
| Refractive Index | 1.435 | 1.435 |
| Light Transmittance | 90% | 90% |
| Color additives | Reactive Blue 247 (Primary Predicate) | • Phthalocyanine green• Carbazole violet• [Phthalocyaninato(2-)] copper• Titanium dioxide• Iron oxides• Mica-based pearlscent pigment |
| Method of Manufacture | Cast Molded | Cast Molded |
Note on "Acceptance Criteria": For this type of device, the "acceptance criteria" effectively boil down to demonstrating that the device is as safe and effective as the predicate device(s) based on comparable technological characteristics and non-clinical and biocompatibility testing. The inclusion of color additives is a distinguishing feature, and the safety of these additives is addressed through biocompatibility testing and their listing in 21 CFR 73 subpart D and 74 subpart D.
2. Sample size used for the test set and the data provenance
Not applicable for this type of device (physical contact lens). The document describes non-clinical and biocompatibility tests, but not a "test set" for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate device, against which the new device's physical, chemical, and biocompatibility properties are compared.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study Proving Acceptance:
The device's acceptance is based on demonstrating substantial equivalence to legally marketed predicate devices (Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens and Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens), as evidenced by:
- Identical Intended Use: Both the subject device and predicates are indicated for correction of refractive ametropia (myopia and hyperopia) in non-diseased eyes with limited astigmatism, for daily or frequent/planned replacement wear. The subject device adds the function of enhancing or altering eye color, which is already present in the secondary predicate (Largan 55 UV Color).
- Similar Technological Characteristics: The document provides a detailed comparison (Table 8) showing that the subject device shares many key physical and optical parameters (lens design, replacement schedule, chemical composition (with primary predicate), water content (with primary predicate), oxygen permeability (with primary predicate), base curve, diameter, center thickness, powers, refractive index (with primary predicate), light transmittance) with one or both predicate devices.
- Non-Clinical Testing: Various physical and optical properties were tested (Back Vertex Power, Radius of Curvature, Overall Diameter, Center Thickness, etc.) to ensure the device performs as expected.
- Biocompatibility Testing: Conducted in accordance with FDA guidance (Premarket Notification [510(k)] Guidance Document for Class II Daily Wear Contact Lenses (1994)), including:
- In-Vitro Cytotoxicity (non-cytotoxic)
- Ocular irritation testing (no ocular irritation)
- Acute systemic toxicity (no acute systemic toxicity)
- Skin Sensitization Study (no skin sensitization)
- Color Additives: The color additives used are listed in 21 CFR 73 subpart D and 74 subpart D, addressing the safety aspect of the color-enhancing feature.
The conclusion is that the "Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens" is as safe, as effective, and performs as well as the predicate devices, thereby meeting the criteria for 510(k) clearance based on substantial equivalence.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.
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 (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
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Indications for Use
Submission Number (if known)
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, NantunDist., Taichung, 40850, Taiwan |
| Phone No. | 886-4-3600-0203 |
| Fax No. | 886-4-3601-0203 |
| info@larganmed.com.tw |
2 Contact Person:
| Phone No. | 886-4-3600-0203 #20246 |
|---|---|
| Fax No. | 886-4-3601-0203 |
| Contact Name | Shih-min Chen |
| shihminchen@larganmed.com.tw |
3 Device Identification:
| Proprietary Name | Largan U38 Color (Polymacon) Daily Wear Sof(hydrophilic) Contact Lens |
|---|---|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Daily Wear,(21 CFR 886.5925, Product Code LPL)Lenses, Soft Contact, Daily Wear (Disposable),(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(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(Polymacon) Daily WearSoft (hydrophilic)Contact Lens | Largan U38(Polymacon) Daily WearSoft (hydrophilic)Contact Lens | Largan 55 UV Color(Ocufilcon D) DailyWear Soft (hydrophilic)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 foruse | The Largan U38 Color(Polymacon) Daily WearSoft (hydrophilic)Contact Lens is a dailywear soft contact lensindicated for daily wearto enhance or alter theapparent color of the eyeand/or for the correctionof refractive ametropia(myopia and hyperopia)in phakic or non-aphakicpersons with non-diseased eyes whoexhibit refractiveastigmatism of 1.00D orless where theastigmatism does notinterfere with visualacuity.Eye care practitionersmay prescribe the lensfor either single-usedisposable wear, or forfrequent/plannedreplacement wear, withcleaning, disinfection,and scheduledreplacement. Whenprescribed for single-use disposable wear,the lens is to bediscarded after eachremoval, therefore nocleaning ordisinfecting is required.When prescribed forfrequent replacement,the lens may bedisinfected using achemical disinfectionsystem only. | The Largan U38(Polymacon) DailyWear Soft (hydrophilic)Contact Lens is a dailywear soft contact lensindicated for thecorrection of refractiveametropia (myopia andhyperopia) in phakic ornon-aphakic personswith non-diseased eyeswho exhibit refractiveastigmatism of 1.00D orless where theastigmatism does notinterfere with visualacuity.Eye care practitionersmay prescribe the lensfor either single-usedisposable wear, or forfrequent/plannedreplacement wear, withcleaning, disinfection,and scheduledreplacement. Whenprescribed for single-usedisposable wear, the lensis to be discarded aftereach removal, thereforeno cleaning ordisinfecting is required.When prescribed forfrequent replacement,the lens may bedisinfected using achemical disinfectionsystem only. | The Largan 55 UVColor (Ocufilcon D)Daily Wear Soft(hydrophilic) ContactLens is a daily wear softcontact lens indicated forthe correction ofrefractive ametropia(myopia and hyperopia)in phakic or non-aphakicpersons with non-diseased eyes whoexhibit refractiveastigmatism of 1.00D orless where theastigmatism does notinterfere with visualacuity.Eye care practitionersmay prescribe the lensfor either single-usedisposable wear, or forfrequent/plannedreplacement wear, withcleaning, disinfection,and scheduledreplacement. Whenprescribed for single-usedisposable wear, the lensis to be discarded aftereach removal, thereforeno cleaning ordisinfecting is required.When prescribed forfrequent replacement,the lens may bedisinfected using achemical disinfectionsystem only. |
| Lens Design | Aspherical | Identical | Identical |
| ReplacementSchedule | Daily Wear/ frequentreplacement | Identical | Identical |
| Chemicalcomposition | Polymacon | Identical | Ocufilcon D |
| Classification | Group I (Nonionic, Lowwater) | Identical | Group IV (Ionic, Highwater) |
| WaterContent | 38% (<50%) | Identical | 55% |
| OxygenPermeability(DK, 35°C ) | 8.0 (Fatt method) | Identical | 19.6 (Fatt method) |
| Base CurveRange(mm) | 8.0~9.0 | Identical | Identical |
| Diameter(mm) | 13.0~15.0 | Identical | Identical |
| CenterThickness | Varies with design andPower (0.100 mm at -3.00D) | Identical | Identical |
| Powers | -10.00D to +3.00D | Identical | Identical |
| RefractiveIndex | 1.435 | Identical | 1.405 |
| LightTransmittance | 90% | Identical | Identical |
| Color additives | • Phthalocyanine green• Carbazole violet• [Phthalocyaninato(2-)]copper• Titanium dioxide• Iron oxides• Mica-based pearlscentpigment | Reactive Blue 247 | • Phthalocyanine green• Carbazole violet• [Phthalocyaninato(2-)]copper• Titanium dioxide• Iron oxides• Chromium-cobalt-aluminum oxide• Mica-based pearlscentpigment |
| Method ofManufacture | 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 ISO 10993-5 with results indicating that the device is non-cytotoxic.
- . Ocular irritation testing was performed on extracts of the finished contact lens and the primary packaging in accordance with ISO 10993-10 and resulted in no ocular irritation.
- . Acute systemic toxicity was performed on the extracts of the finished contact lenses and the primary packaging in accordance with ISO 10993-11 and no acute systemic toxicity was found.
- Skin Sensitization Study in Guinea Pigs performed on the extracts of the finished contact lenses in accordance with ISO 10993-10 and no skin sensitization was found.
10 Conclusion
Comparison to the predicate devices for chemical composition, physical and optical properties, it shows that "Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens" is as safe, as effective and performs as well as the predicate devices.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.