(74 days)
MetroSoft II, MetroTint and MetroLite contact lens are indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes who may have 1.50 diopters or less of astigmatism that does not interfere with visual acuity. The lens power range is -20.00 diopters to +20.00 diopters.
MetroSoft Toric contact lens for daily wear are indicated for use by patients with non-diseased eyes who are not aphakic or aphakic and who have refractive and/or corneal astigmatism of up to 6.00 diopters and require powers from -20.00 to +20.00 diopters.
SaturEyes spherical (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myonia or hyperopia and astigmatism of up to 1.5 Diopters where the astigmatism does not interfere with visual acuity.
SaturEyes Toric (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia and corneal astigmatism of up to 4.00 Diopters or less where the astigmatism does not interfere with visual acuity.
Not Found
This document is a 510(k) clearance letter for contact lenses and does not contain information about the acceptance criteria or a study that proves a device meets those criteria for an AI/ML medical device.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 1998
Mr. Jim Webb, President MetroSoft, Inc. 15802 Vision Drive Pflugerville, TX 78660
Re: K983021
Trade Name: MetroSoft II and MetroLite (polymacon) and SaturEyes (hioxyficon A) soft (hydrophilic) Daily Wear Contact Lenses (parametric release) Regulatory Class: II Product Code: 86 LPL Dated: June 30, 1998 Received: August 31, 1998
Dear Mr. Webb:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
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Page 2 - Mr. Jim Webb, President
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph L. Rosenthal
A. Ralph Rosenthal, M.D Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
II, MetroTint and MetroLite contact lens are indicated for daily wear for the MetroSoft correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes who may have 1.50 diopters or less of astigmatism that does not interfere with visual acuity. The lens power range is -20.00 diopters to +20.00 diopters.
MetroSoft Toric contact lens for daily wear are indicated for use by patients with non-diseased eyes who are not aphakic or aphakic and who have refractive and/or corneal astigmatism of up to 6.00 diopters and require powers from -20.00 to +20.00 diopters.
SaturEyes spherical (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myonia or hyperopia and astigmatism of up to 1.5 Diopters where the astigmatism does not interfere with visual acuity.
SaturEyes Toric (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia and corneal astigmatism of up to 4.00 Diopters or less where the astigmatism does not interfere with visual acuity.
(Concurrence of CDRH, Office if Device Evaluation (ODE)
OR Over the Counter Use Prescription Use
Myra Smith
livision Sign Division of Ophthalmic Devices 510(k) Number_K9830
(Optional Format 1-2-96)
§ 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.