(71 days)
LL Bi-Focal Soft (hydrophilic) Contact Lenses are indicated for daily wear by presbyopic patients with non-diseased eyes who are not aphakic and who have no more than 2.00 diopters of astigmatism and require powers from -6.00 to +6.00 and add powers of +1.50, +2.50 or +3.00.
LL Bi-Focal , Soft (hydrophilic) Contact lens for Daily Wear
The provided text is a 510(k) clearance letter from the FDA for a contact lens device. It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges the trade name "LL Bi-Focal, Soft (hydrophilic) Contact lens for Daily Wear" and states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information based on the given text.
To answer your request, I would need a document detailing the specific study conducted for the device's clearance, including acceptance criteria, study design, results, and statistical analysis.
§ 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.