(237 days)
The Eni-Eye SH Soft K Semi Scleral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irregular astigmatism up to 2.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system.
Eni-Eye SH Soft K Toric Semi Scleral (Efrofilcon A) Soft (hydrophilic) Keratoconus and Irregular Cornea Contact Lens for Daily Wear is indicated for keratoconus management and for the correction of refractive ametropia (myopia and hyperopia) in aphakic and non-aphakic persons that may exhibit refractive and/or corneal astigmatism, or post-refractive surgery corneal irregularity such as irreqular astigmatism up to 5.00 D that does not interfere with visual acuity. The lens may be disinfected with a chemical disinfection system.
Not Found
The provided document is a 510(k) premarket notification letter from the FDA regarding a contact lens. It does not contain information about acceptance criteria or a study proving device performance as typically understood for AI/ML devices. Therefore, I cannot extract the requested information from this document.
The document primarily focuses on:
- FDA's substantial equivalence determination for two contact lens types: Eni-Eye SH Soft K Semi Scleral (Efrofilcon A) and Eni-Eye SH Soft K Toric Semi Scleral (Efrofilcon A).
- The regulatory classification and product codes for these devices.
- A reminder of general controls provisions and other applicable regulations.
- The Indications for Use for both types of contact lenses.
§ 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.