ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. Below the bird-like symbol are three wavy lines, possibly representing water or movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Soflex Isralens Contact Lens Ltd. % Mr. Kevin Walls, RAC Principal Consultant Regulatory insight Inc. 5401 S Cottonwood Court Greenwood Village, CO 80121 Re: K110261 Trade/Device Name: 1) Eni-Eye SH Toric (Efrofilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear - 2) Eni-Eye O SH Multi (Efrofilcon A) Soft (Hydrophilic) Multifocal Contact lens for Daily Wear JUL 2 8 2011 - 3) Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear - 4) Eni-Eye SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear - 5) Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 8, 2011 Received: July 13, 2011 Dear Mr. Walls: 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. {1}------------------------------------------------ Page 2-Mr. Kevin Walls, RAC If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device 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 round in further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean r toure of a rised 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 or and I with all the Act's requirements, including, but not limited to: registration and listing (21 oompy - manu: al: abeling (21 CFR Part 801); medical device reporting (reporting of medical CI it Fart 607); abouting (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 rryou active specific ad reading a leanters offices/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/ReportalProblem/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 Fou may 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 yours, Kesia Alexander for Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosures {2}------------------------------------------------ 510(k) Number (if known): _ K | 026 | Device Name: Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear Indications for Use: The Eni-Eye SH Toric (Efrofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive astigmatism with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lens may be disinfected using a chemical disinfection system. Prescription Use × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Moridulike Virmani (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Page 1 of 5 510(k) Number_K 11026 1 {3}------------------------------------------------ 510(k) Number (if known): Device Name: The Eni-Eye Q SH Multi (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear Indications for Use: The Eni-Eye Q SH Multi (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system. Prescription Use × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Miidulika Vismani (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Page 2 of 5 | CIALLA<br>AND THE FOR<br>JULD' | A con come comments and consideration of the contribution of the first of the first of the first of the first of the first of the first of the first of the first of the first | | | |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| |--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| {4}------------------------------------------------ 510(k) Number (if known): K | | D2 6 | Device Name: Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear Indications for Use: The Eni-Eye Q SH Multi Toric (Efrofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system. Prescription Use × Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Mridulika Virmani (Division Sign-Off) (Division Sigi Oct) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Page 3 of 5 510(k) Number K110261 {5}------------------------------------------------ 510(k) Number (if known): _ K 川ロスム Device Name: ENI-EYE SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear Indications for Use: The ENI-EYE SH Soft K (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system. Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hridulike Virman (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Page 4 of 5 510(k) Number K10261 {6}------------------------------------------------ 510(k) Number (if known): K110261_ Device Name: Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear Indications for Use: The Eni-Eye SH Soft K Toric (Efrofilcon A) Soft (hydrophilic) Keratoconus and irregular cornea Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00DS that does not interfere with visual acuity. The lens may be disinfected with a chemical or heat disinfection system. Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR Ov (21 Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Horidulika Varmani (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices Page 5 of 5 510(k) Number K110261