(119 days)
Not Found
No
The summary describes the material properties and intended use of contact lenses. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is indicated for the "correction of ametropia" which is a refractive error, not a disease. While it manages some irregular corneal conditions like keratoconus, its primary purpose is vision correction, not the treatment or cure of an ailment.
No
The document describes the iSight contact lenses as corrective devices for ametropia, not for diagnosing conditions.
No
The device description clearly states that the device is a physical contact lens made from efrofilcon A, a silicone hydrogel material. It describes the physical properties and manufacturing process of the lens, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The iSight contact lenses are medical devices intended for the correction of vision problems (ametropia, astigmatism, presbyopia) by being placed directly on the eye. They are not used to analyze samples from the body to diagnose a condition.
- Intended Use: The intended use clearly states the lenses are for "correction of ametropia" and management of "irregular corneal conditions," which are physical corrections and management, not diagnostic testing.
- Device Description: The description focuses on the material properties and physical characteristics of the contact lens itself.
- Performance Studies: The performance studies described are related to the safety and effectiveness of the lens material and packaging when used on the eye, not the accuracy of a diagnostic test.
Therefore, the iSight contact lenses fall under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The iSight, 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 nondiseased 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 iSight, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The iSight, multifocal (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 nondiseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, 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 non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, irregular cornea (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 and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
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 (comma separated list FDA assigned to the subject device)
LPL
Device Description
The iSight Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon 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 0.9% 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 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 '' (cm /sec) (ml O ./ml x hPa @ 35 ℃), (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, multifocal toric and irregular cornea 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 step
• Cylinder Power (Toric): -0.25D to -12.00D
• Cylinder Power (Multifocal Toric): -0.25D to -4.00D
• Add Power (Multifocal): +0.50D to +4.00D
The lens is supplied sterile in vials containing a 0.9% saline solution. 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
Eyes (cornea, limbus)
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 vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the iSight (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 iSight (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 iSight, (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 iSight, (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 K100221.
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.
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.
Not Found
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
1 8 2012
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.
The assigned 510(k) number is:
Applicant information:
Date Prepared:
August 3, 2012
Name: Address C&E GP Specialists, Inc. 1015 Calle Amanecer San Clemente, CA 92673
Contact Person:
Phone number:
(800) 346 7603
Principal
Mr. Steve Wagner
Consultant:
Martin Dalsing Medvice Consulting, Inc. 806 Kimball Avenue Grand Junction, CO 81501
Phone number (970) 243-5490
Device Information:
Device Classification: Class II
Classification Number: LPL.
Lenses, Soft Contact, Daily Wear Classification Name:
Trade Name:
iSight, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
1
Page Zoff K121519
Equivalent Devices:
The iSight, 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
"Biofinity (comfilcon A)" by Coopervision, Inc. 510(k) number: K052560
"ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 510(k) number: K983637
Device Description:
The iSight Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon 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 0.9% 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 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 '' (cm /sec) (ml O ./ml x hPa @ 35 ℃), (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, multifocal toric and irregular cornea 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 step |
| • Cylinder Power (Toric) | -0.25D to -12.00D |
| • Cylinder Power (Multifocal Toric) | -0.25D to -4.00D |
| • Add Power (Multifocal) | +0.50D to +4.00D |
The lens is supplied sterile in vials containing a 0.9% saline solution. 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 iSight, 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 nondiseased 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 iSight, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.
The iSight, multifocal (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 nondiseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
3
The iSight, 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 non-aphakic 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.
The iSight, irregular cornea (efrofilcon A) Silicone Hvdrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
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 vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the iSight (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 iSight (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 iSight, (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 iSight, (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 K100221.
4
Substantial Equivalence:
The following matrix illustrates the production method, lens function and material characteristics of the iSight, (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 iSight, (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 patient are the same as those for other Silicone Hydrogel contact lenses.
5
| | Sight, Silicone Hydrogel | telliWave³, Silico Irogel (efrofilco) predicate device. 510(k) K100221 | ooperVision Biofini
edicate devi | ydron Ltd. ActiFresh (lidofilcon A) |
|---------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| tended Us | adicated for daily i sear for the hakk nd naturalian manus with Mohak Natanol and and the mas with Mohak National and manus manus manus manakara Treaccribed Timmand provinsia | icated for olaily i veal for the not appartic persons with mobile cased appear will memorial mobile cased aryes will member and submit and and and and one secribed for m | dicated for daily wear for the sphal prection of visual acuity in aphal
hyperopia | ndicated for daily wear for the orrection of visual acuity in apak nd not aphakic persons with non- iseased eyes with myopia or
nyperopia |
| unctionali | device
same as
predicate | The contact lenses act as a refractive sedium that focus light rays from nea and distant objects on the retina. | The contact lenses act as a refractive medium that focus light rays from near | The contact lenses act as a refrac medium that focus light rays from |
| ndication | ne Hydrogel Sof contact lens
aily wear, Silico (hydrophilic) | eaily wear, Silicone Hydrogel Sc | ly wear, Silicone Hydrogel Sc (hydrophilic) contact lens | aily wear, Soft (hydrophilic) cont
lens |
| oduction Meth | m manufacture
athe-Cut, custo | the-Cut, custom manufactur | ist Molded, mass produ | the-Cut, custom manufactu |
| USAN nam | efrofilcon A | efrofilcon A | comfilcon | idofilcon |
| Vater Conte | 74% | 74% | 48.0% | 74.0% |
| | (cm2/sec) @ 35 degrees C). I method).
60 x 10-11 (ml O2/ml x mm Hp (revised Permeability) (ml O2/ml x mm Hp (revised Patt | 60 x 10-11 (cm2/sec) (ml O2/ml x min Hg @ 35 degrees C) (ml O2/ml x min Hg @ 35 degrees C) (revised Fatt method) | (ml O2/ml x mm Hg @ 35 degrees (ml O2/ml x mm Hg @ 35 degrees (revised Fatt method). | 28 x 10-11 (cm2/scc) {ml O2/ml x mm Hg @ 35 degrees (ml O2/ml x mm Hg @ 35 degrees (revised Fatt method). |
| ecific Grav | 1.139 | 1.139 | 1.142 | ા 'છર( |
. .
Page 6 of 6
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 eagle with three stripes forming its body and wing. The eagle's head is facing right. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 8 2012
C&E GP Specialists
c/o Mr. Martin Dalsing
Official Correspondent
Medvice Consulting, Inc.
2214 Sanford Drive, #7B
Grand Junction, CO 81505
Re: K121519
Trade/Device Name: iSight, 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 6, 2012 Received: September 7, 2012
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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Kesia Alexander
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
510(k): K121519
iSight, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Device Name:
INDICATIONS FOR USE:
The iSight, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves with myopia or hyperopia. 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 iSight, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 12 diopters.
The iSight, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, 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 non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The iSight, irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
Eyecare practitioners are to prescribe the lenses for quarterly 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.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A. Sten
of Ophthalmic. Neurological and Ear, Nose and Throat Devices
$10(k) Number K121519