(57 days)
Not Found
No
The document describes a physical contact lens and its material properties, intended uses, and testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and visual acuity, which are therapeutic functions.
No
The device is a contact lens intended for vision correction, cosmetic alteration, and UV protection, not for diagnosing medical conditions.
No
The device description clearly indicates that the device is a physical contact lens made of a specific material (etafilcon A) with various physical characteristics (tinting, UV blocker). It is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "correction of refractive ametropia (myopia and hyperopia)", "enhanc[ing] or alter[ing] the apparent color of the eye", "correction of distance and near vision in presbyopic", and "correction of visual acuity". These are all related to vision correction and cosmetic appearance, not to the diagnosis of a disease or condition based on in vitro examination of specimens.
- Device Description: The description details the material, tints, and UV blocking properties of the contact lenses. This aligns with a medical device for vision correction and cosmetic use, not an IVD.
- Performance Studies: The performance studies mentioned are related to toxicology, physical/chemical properties, stability, and solution compatibility. These are typical tests for medical devices that come into contact with the body, not for IVDs which analyze biological samples.
- Lack of IVD characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
Therefore, the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens is a medical device, specifically a contact lens, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (spherical) is 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 aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL-TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is to be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for frequent/planned replacement wear the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is to be cleaned, rinsed, and disinfected each time the lens is removed. The etafilcon A contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
When prescribed for single-use disposable wear (See "Wearing Schedule") the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is to be discarded after each removal.
Product codes
LPL
Device Description
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is available as a spherical lens, a bifocal lens, a toric lens, and a toric bifocal lens. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1, 1, 1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Visibility Tinted with UV Blocker, for Daily Wear is tinted blue using Reactive Blue Dye #4 to make the lenses more visible for handling. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will mask or enhance the color of the natural iris. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phytalocyanine green, vat orange 1 and Reactive Blue Dye #4. The cosmetically tinted lens is available in the following opaque colors: Blue, Gray, Green, Honey, Chestnut, Hazel and Sapphire. They are also available in the following enhancer colors: Blue, Green and Aqua.
In the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear, a benzotriazole UV absorbing monomer is used to block UV radiation. The UV Blocking for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear averages 97% in the UVB range of 280 nm to 315 nm. The UV Blocker for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker for Daily Wear averages 82% in the UVA range of 316 nm to 380 nm. The UV Blocker for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Cosmetically Tinted with UV Blocker for Daily Wear averages 81% in the UVA range of 316 nm to 380 nm.
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)
Non-clinical Testing: The following tests were conducted as recommended by the FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact lenses, May 12, 1984: Toxicology Testing, Cytotoxicity using the ISO Agarose Overlay, ISO Ocular Irritation Study, USP & ISO Systemic Toxicity in Mice, Leachables, Physical/Chemical Testing, Stability Testing, Solution Compatibility Testing.
Clinical Testing: The technological characteristics, formulation, manufacturing, and sterilization processes are the same as the predicate device, therefore no clinical data is required.
Key Results: Successful results from chemical/physical, stability and toxicology tests confirm the lenses are within established finished product specifications, remain stable, and are non-toxic and biocompatible with the ocular environment.
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
K 062614
:
Special 510 (k) Summary of Safety and Effectiveness
| Name and
Address of
Submitter | VISTAKON®, Division of Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, Florida 32256 | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Susan Morris | |
| | Phone: (904) 443-1828 | |
| | Date Prepared: September 1, 2006 | |
| Device
Identification
and Class | Common Name: | Soft (hydrophilic) contact lenses for daily
wear |
| | Trade/Proprietary Name: | VISTAKON® (etafilcon A) Soft
(hydrophilic) Contact Lens, Clear and
Tinted (Visibility and/or Cosmetically)
with UV Blocker for Daily Wear |
| | Classification: | Class II, under 21 CFR 886.5925 |
| Predicate
Device
Information | The predicate devices are: 1) VISTAKON® (etafilcon A) Soft
(hydrophilic) Contact Lens, Clear and Visibility Tinted, with UV
Blocker for disposable daily wear, most recently cleared via K051900,
2) ACUVUE®2 COLOURS Brand (etafilcon A ) Soft hydrophilic
Contact Lens with UV Blocker for Daily Wear most recently cleared
via K033969. | |
Continued on next page
Special 510(k) VISTAKON (etafilcon A) Contact Lenses Modification Sentember 1 2006
Page 1 of 5
1
Continued
Device
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Description Wear is available as a spherical lens, a bifocal lens, a toric lens, and a toric bifocal lens. The lens material (etafilcon A) is a copolymer of 2hydroxyethyl methacrylate and methacrylic acid cross-linked with 1, 1, 1 -trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Visibility Tinted with UV Blocker, for Daily Wear is tinted blue using Reactive Blue Dye #4 to make the lenses more visible for handling. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will mask or enhance the color of the natural iris. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phytalocyanine green, vat orange 1 and Reactive Blue Dye #4. The cosmetically tinted lens is available in the following opaque colors: Blue, Gray, Green, Honey, Chestnut, Hazel and Sapphire. They are also available in the following enhancer colors: Blue, Green and Aqua.
In the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear, a benzotriazole UV absorbing monomer is used to block UV radiation. The UV Blocking for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear averages 97% in the UVB range of 280 nm to 315 nm. The UV Blocker for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker for Daily Wear averages 82% in the UVA range of 316 nm to 380 nm. The UV Blocker for VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Cosmetically Tinted with UV Blocker for Daily Wear averages 81% in the UVA range of 316 nm to 380 nm.
Continued on next page
Special 510(k) VISTAKON (etafilcon A) Contact Lenses Modification Contamhar 1 2006
Page 2 of 5
2
Continued
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear Indications for Use and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (spherical) is 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 aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with nondiseased eyes who may have 0.75D of astigmatism or less. The VISTAKON® (etafilcon A) Soft (hydrophilic) TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D of astigmatism or less. The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL-TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eves who may have 10.00D of astigmatism or less. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye. The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear may be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule"). Continued on next page
Special 510(k) VISTAKON (etafilcon A) Contact Lenses Modification September 1. 2006
Page 3 of 5
3
Continued
Indications for Use (continued)
When prescribed for frequent/planned replacement wear the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be cleaned, rinsed, and disinfected each time the lens is removed. The etafilcon A contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
When prescribed for single-use disposable wear (See "Wearing Schedule") the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is to be discarded after each removal.
Technological Characteristics
Comparison to Predicate Device
The table below shows a side-by-side comparison of the label claim characteristics of the modified device to the predicate device.
| Property | Subject Device
Label Claim | Predicate Device
Label Claim |
|-------------------------------------------------------------------------|------------------------------------------|------------------------------------------|
| Water Content, % | 58 | 58 |
| Refractive Index
@ 20° C | 1.40 | 1.40 |
| Dk-Fatt method, non-
edge corrected
(cm²/sec)*
(ml O₂/ml*mmHg) | $28.0 x 10^{-11}$ | $28.0 x 10^{-11}$ |
| Specific Gravity, (calc.) | 0.98 - 1.13 | 0.98 - 1.13 |
| Light Transmission | Minimum 85% | Minimum 85% |
| Base Curve Radius, mm | 7.85 mm to 10.0 mm | 7.85 mm to 10.0 mm |
| Diameter, mm | 12.0 mm to 15.0 mm | 12.0 mm to 15.0 mm |
| Power, Diopters | Varies with power:
0.06 mm to 1.00 mm | Varies with power: 0.06
mm to 1.00 mm |
| Center Thickness, mm | -20.0 D to + 20.0 D | -20.0 D to + 20.0 D |
Continued on next page
Special 510(k) VISTAKON (etafilcon A) Contact Lenses Modification September 1, 2006
Page 4 of 5
4
Continued
:
| Summary of
Non-clinical
Testing | The following tests were conducted as recommended by the FDA
Premarket Notification (510(k)) Guidance Document for Daily Wear
Contact lenses, May 12, 1984:
• Toxicology Testing
• Cytotoxicity using the ISO Agarose Overlay
• ISO Ocular Irritation Study
• USP & ISO Systemic Toxicity in Mice
• Leachables
• Physical/Chemical Testing
• Stability Testing
• Solution Compatibility Testing |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical Testing | The technological characteristics, formulation, manufacturing, and
sterilization processes are the same as the predicate device, therefore no
clinical data is required. |
| Substantial
Equivalence | The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lenses for
daily wear that are the subject of this 510(k) submission are equivalent to
the predicate device. Successful results from chemical/physical, stability
and toxicology tests confirm the lenses are within established finished
product specifications, remain stable, and are non-toxic and
biocompatible with the ocular environment. |
Special 510(k) VISTAKON (etafilcon A) Contact Lenses Modification Sentember 1. 2006
5
Image /page/5/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The words are stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vistakon Division of Johnson & Johnson Vision Care, Inc. c/o Susan Morris Project Manager, Regulatory Submissions 7500 Centurion Parkway, Ste. 100 Jacksonville FL 32256
NOV 1 2006
Re: K062614
Trade/Device Name: Vistakon® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear (packaged in buffered saline with Povidone) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: October 12, 2006 Received: October 17, 2006
Dear Ms. Morris:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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,
Image /page/5/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized depiction of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
6
Page 2 - Susan Morris
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eggleton, M.D.
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
7
Indications for Use Statement
| 510(k) Number | Unknown K062614 |
|---|---|
| Device Name | VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear |
| Indications for Use | The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear (spherical) is 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 aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. |
| The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with non-discased eyes who may have 0.75D of astigmatism or less. | |
| The VISTAKON® (etafilcon A) Soft (hydrophilic) TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D of astigmatism or less. | |
| The VISTAKON® (etafilcon A) Soft (hydrophilic) BIFOCAL-TORIC Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. | |
| The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye. |
Continued on next page:
ﺔ ﺍﻟﻤﺮﺍﺟﻊ - -
11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11
Special 510(k) VISTAKON (etafilcon A)
Contact Lenses Modification
Sentember 1. 2006
:
Page 1 of 2
:
:
8
Indications for Use Statement, Continued
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is to be prescribed for daily wear. Eye Care Practitioners may prescribe the lenses either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement (see "Wearing Schedule").
When prescribed for frequent/planned replacement wear the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is to be cleaned, rinsed, and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
When prescribed for single-use disposable wear (See "Wearing Schedule'') the VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker, for Daily Wear is to be discarded after each removal.
| Labels | Values |
|---|---|
| Prescription Use | X |
| (Part 21 CFR 801 Subpart D) | |
| AND/OR | |
| Over-the-Counter Use | |
| (21 CFR 901 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jon Hets
(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K062614