(10 days)
Not Found
P830037/S042
No
The document describes a standard contact lens and its materials. There is no mention of AI, ML, image processing, or any data-driven algorithms.
No
The device is indicated for correcting visual acuity and presbyopia, which are refractive errors, not diseases or conditions that require therapy. The UV-absorbing property is protective, not therapeutic.
No
These contact lenses are for correcting visual acuity and presbyopia, not for diagnosing conditions.
No
The device description clearly states it is a physical contact lens made of a hydrophilic 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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The FreshLook® Bifocal UV-absorbing Spherical contact lenses are described as devices for the correction of visual acuity and presbyopia. They are worn on the eye, not used to test specimens from the body.
- Intended Use: The intended use clearly states their purpose is for vision correction in persons with non-diseased eyes.
- Device Description: The description focuses on the physical properties and materials of the contact lens itself.
The information provided aligns with a medical device intended for vision correction, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
FreshLook® Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophille) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity.
The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system.
FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The FreshLook® Bifocal UV-absorbing (phemfilcon A) Spherical Soft (Hydrophilic) contact lenses in Handling Tint and Colors are hemispherical shells indicated for the correction of visual acuity in presbyopic patients for daily wear. The generic name (USAN) is phemfilcon A. The form in which the device is to be delivered is a contact lens immersed in 0.9% sodium chloride solution. Exclusive of the saline solution, the lens is a hydrophilic polymer swollen with water, in the polymer/water weight ratio of 45/55 respectively.
The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.
The FreshLook® Bifocal lenses are available in the following parameter range:
Chord Diameter: 12.0 to 15.0 mm
Base Curve: 7.80 to 9.00 mm
Distance Power Zone: 5 mm (colors)
Distance Power Zone: 5 mm to 9 mm (Handling Tint - varies with power)
Increments: 0.25 D
Center Thickness: 0.08 to 0.56 mm (Varies with power)
Distance Powers: -20.00 D to +20.00 D
Bifocal Add Powers: +0.50 D to +3.00 D
Near Power Zone: 1.00 to 3.80 mm
Progressive Power Zone: 1.40 to 4.80 mm
The physical properties of the FreshLook® Bifocal UV-absorbing lens are identical to the FreshLook® UV lens and are as follows:
Specific Gravity: 1.152
Refractive Index: 1.411 @ 25°C
Light Transmittance: 95% (minimum)
Surface Character: Hydrophilic
Water Content: 55%
Oxygen Permeability (Dk): $16.1 x 10^{-11}$ ml O2 cm2 / sec ml mmHg
Oxygen Transmissibility* (Dk/L): $20 x 10^{-9}$ ml O2 cm / sec ml mmHg
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
presbyopic patients, aphakic or not applantic persons
Intended User / Care Setting
eye care practitioner
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
P830037/S042
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SECTION III
510(k) Summary
FreshLook® Bifocal UV-absorbing Contact Lenses
A. Product Summary
1. Name and Address of Applicant:
Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018
Contact Person:
Joseph Foos Vice President Scientific Affairs Phone: (847) 294-3306 (847) 294-3853 Fax:
2. Name of the Device:
Classification Name:
Trade Name:
FreshLook® Bifocal UV-absorbing (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses for Daily Wear
Soft (Hydrophilic) Contact Lenses for Daily Wear.
FreshLook® Bifocal UV-absorbing (phemfilcon A)
Spherical Soft (Hydrophilic) Contact Lenses.
FreshLook® Bifocal Common Name:
Proprietary Name:
Facility Registration Number:
1422160
-
- Identification of predicate device:
FreshLook® UV (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses. FreshLook® Bifocal is an alternate design to the currently marketed FreshLook® UV (phemfilcon A) Contact Lenses.
- Identification of predicate device:
1
4. Description of device:
The FreshLook® Bifocal UV-absorbing (phemfilcon A) Spherical Soft (Hydrophilic) contact lenses in Handling Tint and Colors are hemispherical shells indicated for the correction of visual acuity in presbyopic patients for daily wear. The generic name (USAN) is phemfilcon A. The form in which the device is to be delivered is a contact lens immersed in 0.9% sodium chloride solution. Exclusive of the saline solution, the lens is a hydrophilic polymer swollen with water, in the polymer/water weight ratio of 45/55 respectively.
The components of the FreshLook® Bifocal UV-absorbing lenses are identical to the currently manufactured FreshLook® UV. The lens material (phemfilcon A) is a hydrophilic copolymer of 2-hydroxyethyl methacrylate and 2-ethoxyethyl methacrylate and a proprietary UV absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light.
The FreshLook® Bifocal lenses are available in the following parameter range:
| Chord Diameter: | 12.0 to 15.0 mm |
|---|---|
| Base Curve: | 7.80 to 9.00 mm |
| Distance Power Zone: | 5 mm (colors) |
| Distance Power Zone: | 5 mm to 9 mm (Handling Tint - varies with power) |
| Increments: | 0.25 D |
| Center Thickness: | 0.08 to 0.56 mm (Varies with power) |
| Distance Powers: | -20.00 D to +20.00 D |
| Bifocal Add Powers: | +0.50 D to +3.00 D |
| Near Power Zone: | 1.00 to 3.80 mm |
| Progressive Power Zone: | 1.40 to 4.80 mm |
The physical properties of the FreshLook® Bifocal UV-absorbing lens are identical to the FreshLook® UV lens and are as follows:
| Physical Property | FreshLook® Bifocal UV |
|---|---|
| Specific Gravity | 1.152 |
| Refractive Index | 1.411 @ 25°C |
| Light Transmittance | 95% (minimum) |
| Surface Character | Hydrophilic |
| Water Content | 55% |
| Oxygen Permeability (Dk) | $16.1 x 10^{-11}$ ml O2 cm2 / sec ml mmHg |
| Oxygen Transmissibility* (Dk/L) | $20 x 10^{-9}$ ml O2 cm / sec ml mmHg |
10° ml O₂ cm / sec ml mmHg at 35°C (Dr. Irving Fatt Method)
2
Reference PMA Supplement P830037/S042 Exhibit IV-1, Exhibit IV-2 and subsequent Amendment #1 for a detailed physical description, drawing and canter thickness table of the FreshLook Bifocal UV-absorbing Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lonses submitted to the agency for Real Time Review,
8. Statement of Intended Use
Fresh Look Bifocal UV-absorbing Spherical (phemfilcon A) Soft (Hydrophille) Contact Lenses are indicated for the correction of visual aculty and prosbyopia in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does net interfere with visual acuity. The lons ranges in power from -20.00 to +20.00 not their ore tor daily war.
display for daily war.
display for daily war.
The for daily war.
The letters may be prescribed for Daily Wear to agraduic or not appartic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning. disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disingles chemical disinfection system.
FreshLook Lenses with UV-absorbing monomer help protect against transmission of hannful UV radiation to the comes and into the eye.
C. Technological Characteristics of the Device and Comparison
Reference PMA Supplement P830037/S042 for technological device characteriatios. of the FreshLook® Bifocal UV-absorbing Spherical (phemfijcon A) Soft (Hydrophille) Contact Lenses submitted to the agency for Real Time Review.
D. Device Manufacturing Section
Reference PMA Supplement P830037/S042 for the manufacturing of the Freah Look® Bifocal UV-absorbing Spherical (phermflicon A) Soft (Hydrophillic) Contact Lenses. All device manufacturing information submitted to the FDA In the PMA Supplement P830037/S042 Real Time Review is applicable to this submission.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 4 1999
Mr. Joseph Foos Vice President, Scientific Affairs Wesley Jessen 333 E. Howard Avenue Des Plaines, IL 60018
Re: K991550
Trade Name: FreshLook® Bifocal UV-absorbing (phemfilcon A) Molded Spherical Handling Tint and Colors Soft (Hydrophilic) Contact Lenses for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: May 3, 1999 Received: May 4, 1999
Dear Mr. Foos:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Mr. Joseph Foos
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on. the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS STATEMENT
510(k) Number (if known)
Device Name:
FreshLook® Bifocal UV-absorbing (phomfilcon A) Molded Spherical Handling Tint and Colors Soft (Hvdrophille) Contact Lenses for nondiseased presbyopic eves Dally Wear
Indication for Use:
Spherical
FreshLook® Sphencal (phemfilcon A) Soft (Hydrophilic) Contact Lenses are Indicated for the correction of visual acuity in persons with non-diseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity.
Toric
Fresh Look Toric (chemfilcon A) Soft (Hydrophille) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eves that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 dioptors.
Bifocal
:
Pres
FrashLook® Bifocal UV-absorbing Sphenical (phemfilcon A) Soft (Hydrophille) Contact Lenses are Indicated for the correction of visual aculty and presbyoble in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 0.75 diopters that does not interfers with visual acuity. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
The lenses may be prescribed for Daily Wear in aphakic or not applantic persons. The eye care practitioner may prescribe the lenses in either a single use daily disposable program or in a frequent replacement program with cleaning, disinfection and scheduled replacement. When prescribed in the frequent replacement program, the lenses may be disinfected using a chemical disinfection system. · - - ·· · . .. .. -- · - ----
FreshLock Lenses with UV-absorbing money help protect against transmission of harmful UV rediation to the comes and Into the eye.
(PLEASE DO NOT WRITTERE (OWLTHIS I INE CONTINUE ON ANOTHER PAGE IF NEEDED) Conference of CORH, Office of Device Eveluation (ODE)
| cription Use | OR | Over-The Counter |
|---|---|---|
| -------------- | ---- | ------------------ |
(Division Sign-Off)
Division of Ophthalmic Devices
| 510(k) Number | K991550 |
|---|---|
| --------------- | --------- |
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