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NMR-K Fundus Laser Lens

FDA 510(k)

Class II (US FDA 510(k))

510(k) K910231

by Ocular Instruments, Inc.

Identifiers

510(k) Number
K910231 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 NMR-K Fundus Laser Lens is a diagnostic contact lens designed for ophthalmic use, specifically for examining and treating the posterior pole of the eye. It incorporates a Kapetansky-style contact surface, enabling direct visualization and laser application without the need for methylcellulose.

This device is supplied as a reusable ophthalmic instrument and is intended for use in clinical settings where posterior pole examination and laser treatment are required. It adheres to FDA 510(k) clearance (K910231) under regulatory classification as a Class II medical device, with a product code of HJK. Sterility and MRI safety are not specified in the provided data.

Frequently asked questions

What is the primary purpose of the NMR-K Fundus Laser Lens in clinical practice?

The NMR-K Fundus Laser Lens is designed specifically for ophthalmic use to examine and treat the posterior pole of the eye. Its Kapetansky-style contact surface allows direct visualization and precise laser application, eliminating the need for methylcellulose, which simplifies procedures for clinicians.

Is the NMR-K Fundus Laser Lens intended for single-use or reusable applications?

The NMR-K Fundus Laser Lens is supplied as a reusable ophthalmic instrument, meaning it is intended for repeated use in clinical settings where posterior pole examination and laser treatment are performed. Proper cleaning and maintenance are required to ensure safe and effective reuse.

What regulatory pathway was followed for the FDA clearance of this device?

The NMR-K Fundus Laser Lens received FDA clearance through a traditional 510(k) process, classified as a Class II medical device under product code HJK. The clearance decision was based on a determination of substantial equivalence to a predicate device, with the submission reviewed by the Ophthalmic (OP) Advisory Committee.

Are there multiple sizes or models of the NMR-K Fundus Laser Lens available?

The provided data lists multiple registration numbers and FEI numbers, which may correspond to different models or variants of the NMR-K Fundus Laser Lens. However, the specific sizes or model distinctions are not detailed in the description, so buyers should confirm exact specifications with the manufacturer, Ocular Instruments, Inc.

How should the NMR-K Fundus Laser Lens be stored to maintain its integrity?

While the data does not specify storage conditions, as a reusable ophthalmic instrument, the lens should be stored in a clean, dry environment to prevent contamination and damage. Proper cleaning protocols and storage guidelines should be followed to ensure sterility and functionality before each use.

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 NMR Fundus Laser - Ocular Instruments, K910231 - NMR-K FUNDUS LASER LENS | FDA 510 (k), Nmr-k Fundus Laser Lens 510 (k) FDA Premarket Notification K910231 ..., NMR-K FUNDUS LASER LENS (K910231) — FDA 510 (k) | Innolitics, Ocular Fundus Laser Lens - Optics Incorporated

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) K910231 24 fields · synced Sep 19, 2026