(231 days)
Not Found
No
The document describes a standard contact lens and its physical properties, intended use, and performance studies. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and astigmatism, which are vision corrections, not treatments for diseases or injuries.
No
This device is a contact lens intended for the correction of refractive ametropia (myopia, hyperopia, astigmatism, and presbyopia), not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made from HEMA and water, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive errors (myopia, hyperopia, astigmatism, and presbyopia) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, a physical object placed on the eye to alter vision. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, diagnose, monitor, or predict any disease or condition by examining samples from the human body.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health status. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Largan (hioxifilcon A) 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 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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia 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.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 41% hioxifilcon A and 59% water. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.3% (
§ 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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2017
Largan Medical Co. Ltd. % Jennifer Ting RA Manager Jens Medical Consulting Ltd 6F, No 39, Ln 224, Luzhou Dist., New Taipei City, TW 247 Taiwan R.O.C.
Re: K170286
Trade/Device Name: Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan (hioxifilcon A) 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: August 12, 2017 Received: August 24, 2017
Dear Jennifer Ting:
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. 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.
1
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Denise L. Hampton -S
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) K170286
Device Name
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact Lens Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact lens for ASTIGMATISM Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) contact lens for PRESBYOPIA
Indications for Use (Describe)
The Largan (hioxifilcon A) 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 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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism is indicated daily wear for the correction of ametropia (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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is indicated daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia 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.
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) |
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."
3
510(k) Summary K170286
Preparation Date: August 14, 2017
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 (hioxifilcon A) Daily Wear Soft (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 | CRF 886.5925 |
| Review Panel | Ophthalmic |
| Product Code | LPL/MVN |
1.4 Legally Marketed Equivalent Device:
| Predicate Device Name | AQUASOFT ALL-DAY & ALL-DAY T
(hioxifilcon A) Daily Wear Contact Lens. |
|-----------------------|--------------------------------------------------------------------------|
| Manufacturer | ClearLab Pte Ltd. |
| 510(k) Number | K052290 |
| Product Code | LPL |
1.5 Device Description
The Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens is in hemispherical flexible shells for myopia, hyperopia, astigmatisam and Presbyopia. The lens is made from HEMA containing UV blocker. The composition of the lens is 41% hioxifilcon A and 59% water. A light blue color tinted with "reactive Blue 247" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 1.3% (50%), | 57 % (>50%), |
| Oxygen Permeability (DK, 35°C) | 22 (Fatt method) | 20 (Fatt method) |
| Base Curve Range (mm) | 8.09.0 | 8.0 ~ 9.2 |15.0 | 13.0~15.0 |
| Diameter (mm) | 13.0
| Center Thickness | Varies with design and power (0.102 mm at -1.00D) | Varies with design and power (0.08 mm at -3.00D) |
| Powers | -10.00D to +3.00D | -20.00D to +20.00D |
| Refractive Index | 1.403 | 1.4058 |
| Light Transmittance | 90% | >95% |
| Blue handling tint | Reactive Blue 247 | Reactive Blue 19 |
| Method of Manufacture | Cast Molded | Cast Molded |
1.9 Nonclinical Tests Performed
- Physiochemical studies were conducted according to ISO 18369 First edition 1.9.1 2006-08-15, 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 technical characteristics, formulation, manufacturing process of the subject device are equivalent to AQUASOFT ALL-DAY & ALL-DAY T Daily Wear Contact Lens (K0052290) current marketed by CearLab Pte 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 (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens" is as safe, as effective and performs as well as the predicate device.