(57 days)
The BENZ-G 5X SPHERICAL (hioxifilcon A) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and astigmatism of up to 0.75 Diopters where the astigmatism does not interfere with visual acuty. The lens may be disinfected with either a chemical or a heat disinfection system.
Benz-G 5X (hioxifilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted, lathe-cut)
This document is a 510(k) clearance letter for a contact lens, indicating substantial equivalence to a predicate device. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria in the manner requested. The document describes the regulatory approval of a medical device (a contact lens) based on its equivalence to existing products rather than a performance study against specific acceptance criteria.
Therefore, I cannot provide the requested information from 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.