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K Number
K983021
Device Name
METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
Manufacturer
METROSOFT, INC.
Date Cleared
1998-11-13

(74 days)

Product Code
LPL
Regulation Number
886.5925
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

§ 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.