(58 days)
The NuSoft Spherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.
The NuSoft Toric (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.
The NuSoft Aspherical (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D that does not interfere with visual acuity.
The NuSoft Bifocal (ocufilcon B) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with non-diseased eves that are myopic, or hyperopic, and/or presbyopic and have refractive astigmatism of 4.50D or less that does not interfere with visual acuity.
NuSoft Soft Contact lenses may be disinfected with a chemical (not heat) disinfection system.
NuSoft (ocufilcon B) Spherical, Toric, Aspherical and Bifocal Soft Contact Lenses for Daily Wear (lathe-cut, clear or visibility tinted)
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is an FDA 510(k) clearance letter for Softfocal Company, Inc.'s NuSoft contact lenses. It states that the device is substantially equivalent to legally marketed predicate devices and outlines the indications for use. It does not include details on performance metrics, sample sizes, ground truth establishment, or any comparative effectiveness studies.
§ 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.