(88 days)
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No
The summary describes a standard soft contact lens for vision correction and does not mention any AI/ML components or functionalities.
No
The device corrects refractive errors (myopia, hyperopia, astigmatism, presbyopia) rather than treating a disease or restoring a bodily function.
No
Explanation: This device is a contact lens used for the correction of refractive errors, not for diagnosing medical conditions. It is a treatment device, not a diagnostic one.
No
The device description explicitly states "Soft (hydrophilic) Contact Lens," which is a physical medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The Gelflex Synergy and Triton contact lenses are designed to be worn directly on the eye to correct vision problems (refractive errors and presbyopia). They do not analyze samples from the body.
- Intended Use: The intended use clearly states correction of refractive ametropia and presbyopia, which are conditions related to the eye's ability to focus light, not conditions diagnosed through laboratory testing of bodily fluids or tissues.
Therefore, based on the provided information, this device falls under the category of a medical device, but specifically a contact lens for vision correction, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Gelflex Synergy (hioxifilcon B) Soft Contact Lens (spherical and toric in both clear or blue visitint) is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The Gelflex Synergy (hioxifilcon B) Spherical Lens may be worn by persons who have astigmatism of 1.50 diopters or less which does not interfere with visual acuity. The Gelflex Synergy (hioxifilcon B) Toric Lens may be worn by persons who have astigmatism of up to 4.50 diopters.
The Gelflex (hioxifilocn B) Soft Contact Lens (Triton Translating Bifocal and Triton Translating Toric Bifocal in both clear or blue visitint) is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic and non-aphakic persons with non-diseased eyes. The Gelflex (hioxifilcon B) Triton Translating Bifocal Lens may be worn by persons who have astigmatism of 0.50 diopters or less which does not interfere with visual acuity. The Gelflex (hioxifilcon B) Triton Translating Toric Bifocal Lens may be worn by persons who have astigmatism of up to 6.00 diopters.
The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your care practitioner.
Product codes
LPL
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth. The profiles are connected by a flowing, ribbon-like shape that forms the body of a bird. Encircling the bird image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 01 2003
Gelflex Laboratories c/o Don Ezekiel, AM OD General Manager 3 Hutton Street Osborne Park Perth Western Australia 6017
Re: K030027
Trade/Device Name: The Gelflex Synergy (hioxifilcon B) Soft Contact Lens for Daily Wear (Spherical and Toric in clear or blue visitint; Lathe-cut) The Gelflex (hioxifilcon B) Soft Contact Lens for Daily Wear (Triton Translating Bifocal and Triton Translating Toric Bifocal in clear or blue visitint; lathe-cut) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: December 4, 2002 Received: January 3, 2003
Dear Dr. Ezekiel:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); 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.
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Page 2 - Don Ezekiel, AM OD
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A. Levy Rosenthal
A. Ralph Rosenthal, 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 statement
The Gelflex Synergy (hioxifilcon B) Soft Contact Lens (spherical and toric in both clear or blue visitint) is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. The Gelflex Synergy (hioxifilcon B) Spherical Lens may be worn by persons who have astigmatism of 1.50 diopters or less which does not interfere with visual acuity. The Gelflex Synergy (hioxifilcon B) Toric Lens may be worn by persons who have astigmatism of up to 4.50 diopters.
The Gelflex (hioxifilocn B) Soft Contact Lens (Triton Translating Bifocal and Triton Translating Toric Bifocal in both clear or blue visitint) is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic and non-aphakic persons with non-diseased eyes. The Gelflex (hioxifilcon B) Triton Translating Bifocal Lens may be worn by persons who have astigmatism of 0.50 diopters or less which does not interfere with visual acuity. The Gelflex (hioxifilcon B) Triton Translating Toric Bifocal Lens may be worn by persons who have astigmatism of up to 6.00 diopters.
The lenses may only be prescribed for daily wear and must be cleaned and disinfected as recommended by the eye care practitioner. The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfection systems as recommended by your care practitioner.
$\xi$ 6
(Division Sign-Off)
510(k) Number K050027
Prescription Use
(Per 21 CFR 801.109)