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25MM Peyman Wide Field Yag Laser Lens

FDA 510(k)

Class II (US FDA 510(k))

510(k) K871450

by Ocular Instruments, Inc.

Identifiers

510(k) Number
K871450 FDA 510(k)
FDA Product Code
HJK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.1385 FDA 510(k)
Regulation Number
886.1385 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The 25mm Peyman Wide Field Yag Laser Lens is a diagnostic contact lens composed of polymethylmethacrylate. It is designed for use during YAG laser treatment in the posterior vitreous to optimize image magnification and laser performance.

This device is regulated under FDA 510k clearance as an ophthalmic diagnostic lens. It is intended for professional use in clinical settings, with specific dimensions including a 16.0 mm contact diameter and a 14.7 mm lens height.

Frequently asked questions

What is the primary purpose of the 25mm Peyman Wide Field YAG Laser Lens?

This lens is designed for use during YAG laser procedures in the posterior vitreous. It functions as a diagnostic contact lens to optimize image magnification and improve laser performance for the clinician.

What material is used to manufacture this diagnostic lens?

The 25mm Peyman Wide Field YAG Laser Lens is composed of polymethylmethacrylate, a durable material commonly used in ophthalmic diagnostic contact lenses.

What are the physical dimensions of this lens?

The lens features a contact diameter of 16.0 mm and a total lens height of 14.7 mm, which are specific dimensions intended for professional clinical use.

What is the regulatory status of this device?

This device is regulated under FDA 510k clearance as an ophthalmic diagnostic lens, classified under regulation number 886.1385.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ocular 25mm Peyman Wide Field Lens - Ocular Instruments, Vitreolysis Lenses and Sets - All Products - Ocular Instruments, Ocular® Peyman wide field YAG laser lens - Ambler Surgical, Ocular Instruments OWFY PEYMAN 25mm Widefield YAG Laser Lens | eBay

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ocular Instruments, Inc.

Sources (1)

  • FDA 510(k) K871450 24 fields · synced Oct 6, 2026