(81 days)
The Eni-Eye Q Toric (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is designed to correct ametropia (myopia and hyperopia), presbiopia, and corneal astigmatism in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The Eni-Eye Q (acofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non aphakic persons with non-diseased eyes. The lenses may be disinfected using a chemical disinfection system.
The Eni-Eve Toric (acofilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of astigmatism in persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism. The lenses may be disinfected using a chemical disinfection system.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA regarding several Soflex contact lens products. It states that the FDA has determined the devices are substantially equivalent to legally marketed predicate devices.
Therefore, this document does not contain information about acceptance criteria or a study that proves a device meets acceptance criteria. It is a regulatory approval notice, not a study report. The typical information requested in the prompt (sample sizes, ground truth, expert qualifications, etc.) would be found in a clinical study report or a 510(k) submission summary, neither of which is present in the provided text.
§ 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.