FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC

K122315 · Oculus Private Limited · LPL · Feb 15, 2013 · Ophthalmic

Device Facts

• Record ID: K122315
• Device Name: FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
• Applicant: Oculus Private Limited
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye. The Eye Care Professionals should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

Device Story

FreshKon® 1-Day soft contact lenses (etafilcon A) are daily-wear, single-use lenses designed for refractive myopia correction and cosmetic iris enhancement (color, size, definition). Lenses incorporate UV-blocking properties. Prescribed by eye care professionals for patients with non-diseased eyes and ≤2.00D astigmatism. Lenses are discarded after each use; no cleaning or disinfection required. Device functions as a physical optical corrective and cosmetic accessory.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and material properties identical to the predicate device.

Technological Characteristics

Material: etafilcon A (hydrophilic). Form factor: soft contact lens. Energy source: none. Sterilization: not specified. Connectivity: none. Software: none.

Indications for Use

Indicated for daily wear in aphakic or non-aphakic persons with non-diseased eyes for refractive ametropia (myopia) correction (up to 2.00D astigmatism) and cosmetic iris enhancement. Single-use only; discard after removal.

Regulatory Classification

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.

Predicate Devices

• FreshKon 1-Day (K112656)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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February 15, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Oculus Private Ltd. % Mr. Kevin Walls, RAC Regulatory Insight, Inc. 33 Golden Eagle Lane Littleton CO 80127

Re: K122315

Trade/Device Name: FreshKon® 1-Day Alluring Eyes (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, FreshKon® 1-Day Mosaic (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, FreshKon® 1-Day Colors Fusion (etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, FreshKon® 1-Day Dezigner (etafilcon A) Soft (hydrophilic) 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: February 4, 2013

Received: February 5, 2013

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.

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.

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Page 2 - Mr. Kevin Walls, RAC

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 (OS) 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

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for 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

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## Indications for Use

510(k) Number (if known): K122315

Device Name:_FreshKon® 1-Day Alluring Eyes (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, FreshKon® 1-Day Mosaic (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, FreshKon® 1-Day Colors Fusion (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear, FreshKon® 1-Day Dezigner (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear

Indications For Use:

The FreshKon® Contact Lens is indicated for daily wear to enhance the color and/or the size and/or the definition of the natural iris and/or for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 2.00 diopter (D) or less of astigmatism. It also helps protect against transmission of harmful UV radiation to the cornea and into the eye.

The Eye Care Professionals should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joseph C 2013.02 11 55:28 -05.00

(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K122315