(49 days)
K18123,K013377
No
The summary describes a physical contact lens and its material properties, intended uses, and performance studies related to biocompatibility and physical characteristics. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is indicated for correction of refractive errors and does not treat or cure any disease.
No
This device is a contact lens, intended for the correction of ametropia, astigmatism, and presbyopia, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of a hydrophilic co-polymer, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Largan 55 UV Color Contact Lens is a medical device intended to be worn on the eye for the correction of vision problems (refractive ametropia, astigmatism, presbyopia). It physically interacts with the eye to improve vision.
- Lack of Diagnostic Testing: The description focuses on the lens's physical properties, materials, and intended use for vision correction. There is no mention of analyzing biological samples or providing diagnostic information about a patient's health status.
Therefore, the device falls under the category of a medical device for vision correction, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Largan 55 UV 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 phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for 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 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia) 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 +0.75 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.
Product codes
LPL, MVN
Device Description
The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, hyperopia. astigmatisam and presbyopia. The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA), Methacrylic acid (MAA) and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of saline immersed in normal saline. 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, Mica-based pearlscent pigment, and Chromium-cobalt-aluminum oxide. All color additives used are listed in 21 CFR 73 Subpart D and 74 Subpart D.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests Performed:
- 1.9.1 Physiochemical studies were conducted according to ISO 18369, Ophthalmic optics Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
- 1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
Clinical Studies:
The lens material is the same as Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K18123). The color additives of the subject device are equivalent to BIOMEDICS® UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens (K013377). Therefore, no clinical data is required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services - USA, featuring a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA), with the FDA acronym in a blue square and the full name "U.S. FOOD & DRUG ADMINISTRATION" written in blue text.
November 1, 2018
Largan Medical Co., Ltd. Amy Tien RA Specialist 2F., No. 14, 23rd Rd., Taichung Industrial Park, Nantun Dist., Taichung, 40850 Taiwan
Re: K182523
Trade/Device Name: Largan 55 UV Color (Ocufilcon D) 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: August 30, 2018 Received: September 13, 2018
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 (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182523
Device Name
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft Contact Lens
Indications for Use (Describe)
The Largan 55 UV 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 phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for 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 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of ametropia) 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 +0.75 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.
Type of Use (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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3
K182523
510(k) Summary
Preparation Date: August 30, 2018
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., |
| Taichung, 40850, Taiwan | |
| Phone No. | 886-4-3600-0203 |
| Fax No. | 886-4-3601-0203 |
| info@larganmed.com.tw |
1.2 Contact Person:
| Phone No. | 886-4-3600-0203 |
|---|---|
| Fax No. | 886-4-3601-0203 |
| Contact Name | Amy Tien |
| amytien@larganmed.com.tw |
1.3 Device Identification:
| Proprietary Name | Largan 55 UV Color (Ocufilcon D) Daily Wear Soft 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 |
1.4 Legally Marketed Equivalent Device:
1.4.1 Lens material, lens design, and intended use:
| Predicate Device Name | Largan 55 UV (Ocufilcon D) Daily
Wear Soft (Hydrophilic) Contact
Lens, Largan 55 UV (Ocufilcon D)
Daily Wear Soft (Hydrophilic)
Contact Lens For Astigmatism,
Largan 55 UV (Ocufilcon D)
Daily Wear Soft (Hydrophilic)
Contact Lens For Presbyopia. |
| ----------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
4
| Manufacturer | Largan Medical Inc. |
|---|---|
| 510(k) Number | K181232 |
| Product Code | MVN;LPL |
1.4.2 Color additives:
| Predicate Device Name | BIOMEDICS® UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens |
|---|---|
| ----------------------- | -------------------------------------------------------------------- |
| Manufacturer | Ocular Sciences Inc. |
|---|---|
| 510(k) Number | K013377 |
| Product Code | LPL |
1.5 Device Description
The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is available in hemispherical flexible shells for myopia, hyperopia. astigmatisam and presbyopia. The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is an aspherical design contact lens. The lens material (Ocufilcon D) is a hydrophilic co-polymer by cross-linking 2-Hydroxyethyl methacrylate (HEMA), Methacrylic acid (MAA) and Ethylene Glycol Dimethacrylate (EGDMA). The hydrated lens consists of 45.0% (Ocufilcon D) and 55.0% water by weight of saline immersed in normal saline. 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, Mica-based pearlscent pigment, and Chromium-cobalt-aluminum oxide. All color additives used are listed in 21 CFR 73 Subpart D and 74 Subpart D.
1.6 Indication for Use:
The Largan 55 UV 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 phakic or non-aphakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.
The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated for 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.
5
The Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated for 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 +0.75 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.
1.7 Technological characteristic
Largan 55 UV 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 -3.00 D
- Power:+3.00 to -10.00 D .
Largan 55 UV 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 -3.00 D .
- Power: +3.00 to -10.00 D ●
- Cylinder: -0.25D to -5.00 D ●
- Axis: 10° to 180° (in 10° increments)
Largan 55 UV 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 -3.00 D .
- Power: +3.00 to -10.00 D
- . Additional Powers:+0.75 D to +3.50D
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1.8 Comparison table:
The characteristic comparison to predicate device is summarized in the following table.
| Similarities and differences | |||
|---|---|---|---|
| Item | Device | Predicate (K181232) | Predicate (K013377) |
| Product Name | Largan 55 UV Color | ||
| (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens | BIOMEDICS® UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens | |
| Manufacturer | Largan Medical Inc. | The same | Ocular Sciences Inc. |
| Intended Use | Myopia, Hyperopia, astigmatism, Presbyopia | The same | Myopia, Hyperopia |
| Lens Design | Aspherical, toric, or multifocal | The same | Spherical |
| 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 % (>50%), | The same | The same |
| Oxygen Permeability | |||
| (DK, 35°C ) | 19.6 | ||
| (Fatt method) | The same | The same | |
| Base Curve Range | |||
| (mm) | 8.0~9.0 | The same | 8.0~9.2 |
| Diameter (mm) | 13.0~15.0 | The same | 12.0~15.0 |
| Center Thickness | Varies with design and power | ||
| (0.084 mm at -3.00D) | The same | 0.025mm~40mm | |
| Powers | -10.00D to +3.00D | The same | -20.00D to +10.00D |
| Refractive Index | 1.405 | The same | The same |
7
| Light Transmittance | 90% | The same | 97% |
|---|---|---|---|
| Color additives | • Phthalocyanine green | ||
| • Carbazole violet | |||
| • [Phthalocyaninato(2-) | |||
| )]copper | |||
| • Titanium dioxide | |||
| • Iron oxides | |||
| • Chromium-cobalt- | |||
| aluminum oxide | |||
| • Mica-based pearlscent | |||
| pigment | Reactive Blue 246 | • Phthalocyanine green | |
| • Carbazole violet | |||
| • [Phthalocyaninato(2-) | |||
| )]copper | |||
| • Titanium dioxide | |||
| • Iron oxides | |||
| • Chromium-cobalt- | |||
| aluminum oxide |
1.9 Nonclinical Tests Performed
- 1.9.1 Physiochemical studies were conducted according to ISO 18369, Ophthalmic optics Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
- 1.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
1.10 Clinical Studies
The lens material is the same as Largan 55 UV (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens (K18123). The color additives of the subject device are equivalent to BIOMEDICS® UV Colors (Ocufilcon D) Soft (Hydrophilic) Contact Lens (K013377). Therefore, no clinical data is required.
1.11 Conclusion
Comparison to the predicate devices for chemical composition, physical and optical properties, it shows that " Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens " is as safe, as effective and performs as well as the predicate devices