ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL

• K Number: K052703
• Device Name: ALDEN CLASSIC (POLYMACON) MULTIFOCAL (SPHERICAL AND TORIC), ALDEN CLASSIC 55 (METHAFILCON A) MULTIFOCAL (SPHERICAL
• Manufacturer: ALDEN OPTICAL LABS., INC.
• Date Cleared: 2005-11-10 ( 43 days)
• Product Code: LPL
• Regulation Number: 886.5925
• Type: Traditional
• Panel: OP
• Reference & Predicate Devices: K020942 , K040523 , K042079 , K050868 , K043232 , K160249 , K180862 , K100867

Intended Use

The Alden Classic (polymacon), Alden Classic 55 (methafilcon A), Alden HP 49 (hioxifilcon B) and Alden HP 59G (hioxifilcon A) Multifocal (Spherical and Toric) 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 refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia. The lenses are available for either conventional or planned replacement modalities.

Device Description

Alden Classic (polymacon) Multifocal Contact Lens (Spherical and Toric designs); Alden Classic 55 (methafilcon A) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 49 (hioxifilcon B) Multifocal Contact Lens (Spherical and Toric designs); Alden HP 59G (hioxifilcon A) Multifocal Contact Lens (Spherical and Toric designs).

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA to Alden Optical Laboratories, Inc. regarding their multifocal contact lenses.

**This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for AI detection algorithms.

Therefore, I cannot provide the requested information based on the given input text. The document is a regulatory approval letter for a medical device (contact lenses), not a study report or technical specification for an AI-powered diagnostic device.

Regulation Number and Section

§ 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.