CONTACT LASER & DIAGNOSTIC LENSES

• K Number: K023221
• Device Name: CONTACT LASER & DIAGNOSTIC LENSES
• Manufacturer: VOLK OPTICAL, INC.
• Date Cleared: 2002-10-11 ( 14 days)
• Product Code: HJK
• Regulation Number: 886.1385
• Type: Special
• Panel: OP
• Reference & Predicate Devices: N/A

Intended Use

The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA regarding the "Contact Laser & Diagnostic Lenses" by Volk Optical, Inc. It determines that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, or ground truth establishment. The document is a regulatory approval notice, not a study report.

Therefore, I cannot provide the requested information from the given input.

Regulation Number and Section

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.