(253 days)
Not Found
No
The 510(k) summary describes a physical contact lens and its material properties. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The manufacturing process is described as lathe-cut, and the clinical data relies on equivalence to a previously cleared device.
No
The device is indicated for the correction of ametropia (myopia and hyperopia), which corrects vision, but does not provide therapy for a disease or condition.
No
Explanation: The device is a contact lens used for correction of ametropia (myopia and hyperopia) and astigmatism, not for diagnosing eye conditions.
No
The device description clearly states it is a physical contact lens made from efrofilcon A, a silicone hydrogel material. It is a tangible medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The C.VUE Advanced Definitive contact lenses are designed to be worn directly on the eye to correct vision problems (ametropia, astigmatism, presbyopia). They are a therapeutic and corrective device, not a diagnostic one that analyzes biological samples.
- Intended Use: The intended use clearly states the lenses are for "correction of ametropia" and other vision issues. There is no mention of analyzing biological samples or providing diagnostic information.
- Device Description: The description focuses on the material properties and physical characteristics of the contact lens itself, not on any components or processes related to analyzing biological specimens.
Therefore, the C.VUE Advanced Definitive contact lenses fall under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The C.VUE Advanced Definitive, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The C.VUE Advanced Definitive, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 10 diopters.
The C.VUE Advanced Definitive, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The C.VUE Advanced Definitive, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Product codes
LPL
Device Description
The C.VUE Advanced Definitive Silicone Hydrogel Soft Contact Lenses are fabricated from efrofileon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The Physical properties of the lens are:
Refractive Index: 1.38
Light Transmission: greater than 97%
Surface Character: hydrophilic
Water Content: 74 %
Specific Gravity: 1.048 (hydrated)
Oxygen Permeability: 59.8 x 10-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method).
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, toric, multifocal and multifocal toric configurations with the following features and properties.
• Chord Diameter: 12.0 mm to 16.00 mm
• Center Thickness: 0.01 mm to 0.50 mm
• Base Curve: 8.0 mm to 9.5 mm
• Power Range: -20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric): -0.25D to -10.00D
• Cylinder Power (Multifocal Toric): -0.25D to -4.00D
• Add Power (Multifocal): +0.50D to +3.00D
The lens is supplied sterile in glass vials containing a bution. The vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cornea / Eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare 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: A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the C.VUE Advanced Definitive (efrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation, All other testing was conducted according to valid scientific protocols.
Key results:
• Lenses supplied in glass vials are sterile for the indicated shelf-life,
• The packaging material and extracts are not toxic and not irritating, and
• Lens physical and material properties are consistent with currently marketed lenses.
Clinical Data: The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k). The C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221. The C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenses have the identical manufacturing process (lathe-cut versus lathe-cut) as the marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K 100221.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K100221, K082393, K052560, K983637
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
PAGE 1 OF 6
OCT 2 8 2010
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
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.
K100456 The assigned 510(k) number is:
Applicant information:
Date Prepared:
September 22, 2010
Name: Address Unilens CORP USA 10431 72nd Street North Largo, FL 33777
Mr. Michael Pecora
President
(727) 544-2531
Contact Person:
Phone number:
Consultant:
Martin Dalsing Medvice Consulting, Inc. 806 Kimball Avenue Grand Junction, CO 81501
(970) 243-5490 Phone number
Device Information:
Device Classification: Class II
Classification Number: LPL
Lenses, Soft Contact, Daily Wear Classification Name:
Trade Name:
C·VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
1
K100456
PAGE 2 OF 6
Equivalent Devices:
The C.VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lenses (efrofilcon A) are substantially equivalent to the following predicate devices:
Predicate devices:
"IntelliWave", Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K100221
"C.VUE Advanced (hioxifilcon D)" by Unilens CORP USA 510(k) number; K082393
"Biofinity (comfilcon A)" by Coopervision, Inc. 510(k) number; K052560
"ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 510(k) number: K983637
Device Description:
The C.VUE Advanced Definitive Silicone Hydrogel Soft Contact Lenses are fabricated from efrofileon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
2
The Physical properties of the lens are:
| Refractive Index | 1.38 |
|---|---|
| Light Transmission | greater than 97% |
| Surface Character | hydrophilic |
| Water Content | 74 % |
| Specific Gravity | 1.048 (hydrated) |
| Oxygen Permeability | 59.8 x 10-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method). |
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, toric, multifocal and multifocal toric configurations with the following features and properties.
| • Chord Diameter | 12.0 mm to 16.00 mm |
|---|---|
| • Center Thickness | 0.01 mm to 0.50 mm |
| • Base Curve | 8.0 mm to 9.5 mm |
| • Power Range | -20.00D to +20.00D in 0.25 steps |
| • Cylinder Power (Toric) | -0.25D to -10.00D |
| • Cylinder Power (Multifocal Toric) | -0.25D to -4.00D |
| • Add Power (Multifocal) | +0.50D to +3.00D |
The lens is supplied sterile in glass vials containing a bution. The vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.
Intended Use:
The C.VUE Advanced Definitive, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The C.VUE Advanced Definitive, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 10 diopters.
The C.VUE Advanced Definitive, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
3
The C.VUE Advanced Definitive, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
Testing:
Non-clinical Testing A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the C.VUE Advanced Definitive (efrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation, All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the C.VUE Advanced Definitive (efrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that: � Lenses supplied in glass vials are sterile for the indicated shelf-life, The packaging material and extracts are not toxic and not irritating, and . Lens physical and material properties are consistent with currently marketed . lenses. Clinical Data The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k). The C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221. The C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenses have the identical manufacturing process (lathe-cut versus lathe-cut) as the marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K 100221.
4
Substantial Equivalence:
The following matrix illustrates the production method, lens function and material characteristics of the C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.
Conclusions Drawn from Studies
Validity of Scientific Data
Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7
Substantial Equivalence
Information presented in this Premarket Notification establishes that the C VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.
Risks and Benefits
The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.
5
| | C-VUE Advanced Definitive,
Silicone Hydrogel
(efrofilcon A)
New Device | IntelliWave³, Silicone
Hydrogel (efrofilcon A)
predicate device | Unilens C-VUE Multifocal
(hioxifilcon D)
predicate device | CooperVision Biofinity
(comfilcon A)
predicate device | Hydron Ltd. ActiFresh 400
(lidofilcon A)
predicate device |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear for the
correction of visual acuity in aphakic
and not aphakic persons with non-
diseased eyes with myopia or
hyperopia. The lens may also be
prescribed for management of
irregular corneal conditions such as
keratoconus and post graft fitting. | Indicated for daily wear for the
correction of visual acuity in aphakic
and not aphakic persons with non-
diseased eyes with myopia or
hyperopia. The lens may also be
prescribed for management of
irregular corneal conditions such as
keratoconus and post graft fitting. | Indicated for daily wear for the
correction of visual acuity in aphakic
and not aphakic persons with non-
diseased eyes with myopia or
hyperopia, posses refractive
astigmatism and/or are Presbyopic. | Indicated for daily wear for the
correction of visual acuity in aphakic
and not aphakic persons with non-
diseased eyes with myopia or
hyperopia. | Indicated for daily wear for the
correction of visual acuity in aphakic
and not aphakic persons with non-
diseased eyes with myopia or
hyperopia. |
| Functionality | same as
predicate device | The contact lenses act as a refractive
medium that focus light rays from near
and distant objects on the retina. | The contact lenses act as a refractive
medium that focus light rays from near
and distant objects on the retina. | The contact lenses act as a refractive
medium that focus light rays from near
and distant objects on the retina. | The contact lenses act as a refractive
medium that focus light rays from near
and distant objects on the retina. |
| Indications | Daily wear, Silicone Hydrogel Soft
(hydrophilic) contact lens | Daily wear, Silicone Hydrogel Soft
(hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact
lens | Daily wear, Silicone Hydrogel Soft
(hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact
lens |
| Production Method | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured | Cast Molded, mass produced | Lathe-Cut, custom manufactured |
| USAN name | efrofilcon A | efrofilcon A | hioxifilcon D | comfilcon A | lidofilcon A |
| Water Content | 74% | 74% | 54% | 48.0% | 74.0% |
| Oxygen Permeability | $60 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $60 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $23.00 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $128 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ | $28 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$ |
| Specific Gravity | 1.139 | 1.139 | 1.142 | 1.142 | 1.060 |
K100456
PAGE 6 OF 6
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
Unilens Corp USA c/o Medvice Consulting, Inc. Mr. Martin Dalsing Official Correspondent 806 Kimball Avenue Grand Junction, CO 81501
OCT 2 8 2010
Re: K100456
Trade/Device Name: C-VUE Advanced Definitive Silicone Hydrogel Daily Wear Soft
Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 22, 2010 Received: September 24, 2010
Dear Mr. Dalsing:
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.
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.
7
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.
Sincerely yours,
Deborah falls
Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
INDICATIONS FOR USE STATEMENT
Device Name: C.VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
INDICATIONS FOR USE:
OCT 2 8 2010
The C.VUE Advanced Definitive, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The C.VUE Advanced Definitive, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 10 diopters.
The C.VUE Advanced Definitive, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The C.VUE Advanced Definitive, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the Iens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) or
(Division Sign-Off) (Optional Format 1-2-96)
Over The Counter Use
Marc Polloy
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100456