(111 days)
Not Found
No
The 510(k) summary describes a standard contact lens made of a specific material and design. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies focus on material properties and clinical safety/efficacy, not on algorithmic performance.
No.
A therapeutic device is typically used for the treatment or prevention of a disease, injury, or other medical condition. This device, a contact lens, is indicated for the correction of ametropia (myopia and hyperopia), which is a refractive error, not a disease or injury that requires therapy.
No
The device is a contact lens used for the correction of ametropia, not for diagnosis. Its intended use is to correct vision, not to identify or monitor a medical condition.
No
The device is a physical contact lens made of specific materials, not a software program. The description details its physical properties, composition, and manufacturing process.
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 vision (ametropia) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties and materials of a contact lens designed for wear on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the body (like blood, urine, or tissue) or to provide information for the diagnosis of a disease or condition.
- Anatomical Site: The anatomical site is the cornea, which is where a contact lens is worn for vision correction.
- Performance Studies: The performance studies focus on the safety and clinical performance of the lens in correcting vision and being worn on the eye, not on diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00 diopter (D) or less of astigmatism.
Eye Care Professionals may prescribe the for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280mm -315nm), and >70% in the UVA range (316nm - 380nm).
The Oualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is manufactured in a spherical design configuration. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 13.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.080 mm @ -3.00 D | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 8.00 mm to 9.50 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +20.00D to -20.00D | When 0.00 |
§ 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
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January 18, 2022
Unicon Optical Co., Ltd. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068
Re: K213216
Trade/Device Name: Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: December 6, 2021 Received: December 9, 2021
Dear Bret Andre:
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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medical-devicereporting-mdr-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
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
2
Indications for Use
510(k) Number (if known) not yet assigned
Device Name
Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
Indications for Use (Describe)
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00 diopter (D) or less of astigmatism.
Eye Care Professionals may prescribe the for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, the lens is to be discarded after each removal. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Premarket Notification
510 (k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
SUBMITTER I.
| Date Prepared: | September 24th, 2021 |
|---|---|
| Name: | UNICON OPTICAL CO., LTD. |
| Address: | No.16, Gongye E. 9th Rd. |
| Hsinchu Science Park, Baoshan Township | |
| Hsinchu County Hsinchu – District, | |
| TAIWAN 30075 | |
| Contact Person: | Nick Liao |
| Director | |
| Phone number: | +886-4-23551233 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 |
(503) 372-5226
II. DEVICE
Phone number:
| Trade Name: | Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens |
|---|---|
| Common | |
| Name: | Contact Lens, Daily Wear |
| Classification | |
| Name: | Soft (hydrophilic) Contact Lens (21 CFR 886.5925) |
| Regulatory | |
| Class: | Class II |
| Product Codes: | LPL; MVN |
Purpose of 510(k) Submission:
~ New Device ~
4
510(k) Premarket Notification
III. PREDICATE DEVICE
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is substantially equivalent to the following predicate device(s):
- "ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens" I By Johnson & Johnson Vision Care, Inc. 510(k) number; K160212 Primary Predicate
IV. DEVICE DESCRIPTION
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is a hemispherical shell with a molded spherical base curve and a molded front surface. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).
The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens contains C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling. The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280mm -315nm), and >70% in the UVA range (316nm - 380nm).
The Oualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is manufactured in a spherical design configuration. The material properties and available parameters of the finished lenses are as follows:
| Parameter | Range | Tolerance |
|---|---|---|
| Chord Diameter | 13.00 mm to 15.00 mm | ±0.20 mm |
| Center Thickness | 0.080 mm @ -3.00 D | When ≤ 0.10 mm → ±0.010 mm + 10% |
| When > 0.10 mm → ±0.015 mm + 5% | ||
| Base Curve | 8.00 mm to 9.50 mm | ±0.20 mm |
| Back Vertex Power (F'v) | +20.00D to -20.00D | When 0.00 |