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MP-1 Micro Perimeter

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K023719

by Nidek Technologies Srl

Identifiers

510(k) Number
K023719 FDA 510(k)
FDA Product Code
HKI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.1120 FDA 510(k)
Regulation Number
886.1120 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MP-1 Micro Perimeter is a diagnostic ophthalmic device classified as a camera, designed for assessing retinal function and structure. It captures infrared live sequences of the retina to evaluate visual field sensitivity, fixation stability, and scotoma characteristics in patients with retinal diseases.

This device is intended for use in clinical settings by trained ophthalmologists or optometrists. Supplied as a reusable instrument, it requires proper calibration and maintenance per manufacturer guidelines. Authorized under FDA 510K and MDR, the MP-1 is intended for non-invasive retinal imaging and perimetry, with no MRI safety restrictions specified. No sterility or single-use designation is indicated.

Frequently asked questions

What clinical assessments can the MP-1 Micro Perimeter perform, and why is this useful for retinal disease patients?

The MP-1 Micro Perimeter assesses retinal function and structure by capturing infrared live sequences to evaluate visual field sensitivity, fixation stability, and scotoma characteristics. This is particularly useful for patients with retinal diseases because it provides detailed insights into areas of vision loss (scotomas), how well the patient can maintain stable eye fixation, and overall sensitivity across the retina—helping clinicians monitor progression or response to treatment in conditions like macular degeneration or retinal dystrophies.

Is the MP-1 Micro Perimeter a single-use device, or can it be reused in a clinical setting? If reusable, what maintenance is required?

The MP-1 Micro Perimeter is not single-use—it is designed as a reusable instrument. Since it is intended for clinical use, it must be properly calibrated and maintained according to the manufacturer’s guidelines to ensure accurate and reliable performance. Regular servicing and adherence to cleaning protocols are essential to prevent cross-contamination and preserve functionality.

Does the MP-1 Micro Perimeter have any restrictions regarding MRI compatibility, and what does this mean for patients?

The MP-1 Micro Perimeter has no specified MRI safety restrictions mentioned in its documentation. This means patients who use the device can generally undergo MRI scans afterward without immediate concerns about interference or safety hazards from the device itself. However, clinicians should always verify compatibility with any implanted devices or materials the patient may have.

What regulatory pathways has the MP-1 Micro Perimeter undergone, and what does this indicate about its approval status?

The MP-1 Micro Perimeter has been authorized through FDA 510K clearance and MDR (Medical Device Regulation) compliance, indicating it has met the necessary regulatory standards for safety and effectiveness in the U.S. and EU markets. The 510K pathway demonstrates it is deemed substantially equivalent to a legally marketed predicate device, while MDR compliance aligns with current European medical device regulations. These approvals confirm its suitability for clinical use in ophthalmology.

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: [PDF] SEP 2 8 - accessdata.fda.gov, Microperimeter - NIDEK, [PDF] NIDEK CO., LTD. - Noviello Intermed Srl, [PDF] Microperimeter - NIDEK

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Nidek Technologies Srl

Sources (2)

  • FDA 510(k) K023719 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026