K Number
K103132
Device Name
FRESHKONALLURING EYES, FRESHKON COLORS FUSION, FRESHKONCOLORS FUSION SPARKLERS, FRESHKON MOSAIC, FRESHKON GLITZI
Date Cleared
2011-09-08

(318 days)

Product Code
Regulation Number
886.5925
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The FreshKon® (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be used to enhance or alter the apparent color of the eye. The lenses may be disinfected using a chemical disinfection system.
Device Description
Not Found
More Information

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Not Found

No
The summary describes a standard contact lens for vision correction and cosmetic purposes, with no mention of AI or ML technology.

No
The primary indication of the device is for the correction of refractive ametropia (myopia) and to alter the apparent color of the eye, which are not considered therapeutic uses.

No
Explanation: The device is a contact lens used for correcting refractive ametropia and altering eye color, not for diagnosing diseases or conditions.

No

The device is described as contact lenses, which are physical medical devices, not software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the correction of refractive ametropia (myopia) and to enhance or alter the apparent color of the eye. This is a direct interaction with the eye for vision correction and cosmetic purposes.
  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The FreshKon® contact lenses do not involve testing bodily samples.
  • Anatomical Site: The anatomical site is the eyes, which is where the device is directly applied, not where a sample is taken from.

The description clearly indicates a medical device for vision correction and cosmetic enhancement, not a diagnostic test performed on a sample.

N/A

Intended Use / Indications for Use

The FreshKon® (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be used to enhance or alter the apparent color of the eye. The lenses may be disinfected using a chemical disinfection system.

Product codes

LPL

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

eyes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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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.

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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.

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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

Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH &" is vertically oriented and curves along the left side of the logo, with "HUMAN SERVICES" appearing below it.

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

Oculus Private Limited c/o Mr. Kevin Walls, RAC Principal Consultant Regulatory Insight, Inc. 5401 S. Cottonwood Court Greenwood Village, Colorado 80121

SEP - 8 2011

Re: K103132

Trade/Device Name: FreshKon® Alluring Eyes, FreshKon® Colors Fusion, FreshKon® Colors, Fusion Sparklers, FreshKon® Mosaic, FreshKon® Glitzi (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: August 23, 2011 Received: August 24, 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.

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.

1

Page 2 - Mr. Kevin Walls

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/CDRJ-VCDRHOffices/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.

Sincerely yours,

Sincerely yours,

Kesia Alexander

image

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

Enclosure

2

Indications for Use

510(k) Number (if known): K103132

Device Name:

    1. FreshKon®Alluring Eyes (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear,
    1. FreshKon®Colors Fusion (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear,
    1. FreshKon®Colors Fusion Sparklers (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear,
    1. FreshKon® Mosaic (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear,
    1. FreshKon® Glitzi (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear.

Indications for Use:

The FreshKon® (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear are indicated for daily wear for the correction of refractive ametropia (myopia) in aphakic or not-aphakic persons with non-diseased eyes. The lenses may be used to enhance or alter the apparent color of the eye. The lenses may be disinfected using a chemical disinfection system.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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)

Marc Robboy

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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510(k) Number K103132