(43 days)
The Toricolors (hioxifilcon D) Soft Contact Lenses for daily wear (power range -12.00D to +6.00D) is indicated for the correction of visual acuity in aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
The soft contact lens with or without refractive power act to enhance or alter the apparent color of the eye.
Not Found
The provided document is a 510(k) premarket notification letter for a medical device (PolyDev Soft Contact Lenses). It is not a study report and therefore does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, or device performance against those criteria.
The letter acknowledges receipt of the 510(k) submission and states that the device is substantially equivalent to legally marketed predicate devices. It also includes an "Indications for Use" statement, defining what the device is intended for.
Therefore, I cannot provide the requested information based on the provided text.
To answer your questions, I would need a study report or clinical trial summary that details the performance testing conducted for the PolyDev Soft Contact Lenses. This document only provides the regulatory approval letter.
§ 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.