(398 days)
GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens indicated for daily wear to correction of refractive ametropia (myopia and hyperopia) in aphakit and/or not rol ually weat to contection of Formative astigmative astigmatism up to 0.50 dioplers aphakic persons with non discussu eyos the ons is available clear or colored and may be used to enhance or alter the apparent color of the eye.
Eye care practitioners may prescribe the lens for frequent wear, with cleaning, disinfecting, and scheduled replacement. (see Wearing Schedule).
GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens
This document is a 510(k) premarket notification approval letter for a contact lens. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is primarily administrative correspondence from the FDA to the device manufacturer, confirming substantial equivalence to a legally marketed predicate device.
Therefore, I cannot extract the requested information based on 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.