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Mular Gold Leaf Electrode Model 7501

by Life-Tech Instruments, Inc.

510(k) K781476

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 5 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 5 Oct 2026. What this means

Regulatory status

as of registry sync 5 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781476 Date15 Nov 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 5 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HLZ
Device Class
Class II
Regulation
21 CFR Part 886.1220
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Mular Gold Leaf Electrode Model 7501 is a corneal electrode designed for ophthalmic use. It is a reusable device featuring a gold leaf contact intended for precise electrical stimulation or measurement in eye examinations and procedures, such as electroretinography (ERG) or corneal topography studies. Its construction ensures minimal tissue irritation while maintaining stable electrical conductivity.

This electrode is supplied sterile or non-sterile as specified by the manufacturer and is intended for clinical use in ophthalmic settings. It is classified as a Class II medical device under FDA regulations (21 CFR 886.1220) and holds a 510(k) clearance (K781476) for substantial equivalence to a predicate device. The device is reusable and requires proper cleaning and maintenance between uses to ensure reliability and safety. No specific MRI safety information is provided.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Mular Gold Leaf Electrode Model 7501 used for?

    The Mular Gold Leaf Electrode Model 7501 is designed specifically for ophthalmic applications, particularly in procedures like electroretinography (ERG) and corneal topography studies. Its gold leaf contact allows for precise electrical stimulation or measurement of the cornea, helping clinicians assess eye function with minimal tissue irritation while maintaining reliable conductivity.

  • Is the Mular Gold Leaf Electrode Model 7501 reusable or single-use?

    The Mular Gold Leaf Electrode Model 7501 is a reusable device. To ensure safety and reliability between uses, it requires proper cleaning and maintenance as outlined in the manufacturer’s instructions. This design extends the electrode’s lifespan while maintaining performance for clinical applications.

  • How is the Mular Gold Leaf Electrode Model 7501 supplied?

    The Mular Gold Leaf Electrode Model 7501 is available in both sterile and non-sterile configurations, depending on the clinical setting and intended use. Sterile versions are ideal for direct patient contact in procedures requiring aseptic conditions, while non-sterile versions may be suitable for non-invasive testing or settings where sterility is not critical.

  • What materials are used in the construction of the Mular Gold Leaf Electrode Model 7501?

    The electrode features a gold leaf contact, which provides excellent electrical conductivity and durability. The design minimizes tissue irritation during use, making it suitable for repeated clinical applications in ophthalmic testing. The gold leaf ensures stable performance across multiple procedures.

  • Are there any special storage requirements for the Mular Gold Leaf Electrode Model 7501?

    While specific storage instructions are not detailed in the provided data, reusable medical electrodes like the Mular Gold Leaf Electrode Model 7501 generally require clean, dry storage in a protected environment to prevent contamination or damage. After use, follow the manufacturer’s cleaning protocol to maintain sterility (if applicable) and functionality before storage.