(86 days)
The Soft K. (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and notaphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.
The Soft K. Toric (xylofilcon A) Soft (hydrophilic) Keratoconus Contact Lens for Daily Wear is indicated for daily wear for persons requiring keratoconus management and for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected with a chemical or heat disinfection system.
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for contact lenses. It does not contain any information about acceptance criteria for a device, nor does it describe a study to prove a device meets acceptance criteria.
The letter primarily:
- Confirms the substantial equivalence of the Soflex Soft K. and Soft K. Toric contact lenses to legally marketed predicate devices.
- States the regulation number, name, and class for the device.
- Outlines general controls provisions and other compliance requirements.
- Provides contact information for further advice.
- Includes the intended Indications for Use for both contact lens types.
Therefore, I cannot provide the requested table and study details based on the input 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.