(25 days)
The PROMED 38 SOFBLU (Toric) (polymacon) SOFT CONTACT LENSES for daily wear are indicated for the correction of visual acuity in not aphakic persons with non-diseased eyes with myopia or hyperopia and refractive astigmatism not exceeding 10 Diopters.
The PROMED 38 SOFBLU (Spherical) (polymacon) 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. The lens may be worn by persons who exhibit reffactive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.
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This document is a 510(k) premarket notification letter from the FDA for a contact lens. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot generate 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.