Nidek Digital Keratometer
FDA 510(k)Class III (US FDA 510(k))
by Nidek, Inc.
Identifiers
- 510(k) Number
- K842892 FDA 510(k)
- FDA Product Code
- HQL FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.3600 FDA 510(k)
- Regulation Number
- 886.3600 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Nidek Digital Keratometer is a diagnostic device classified as a keratometer, used to measure the curvature of the cornea. It provides precise readings of corneal radius and refractive power, aiding in the assessment of corneal topography and the fitting of contact lenses or intraocular lenses.
This device is intended for use in ophthalmic settings and is supplied as a reusable instrument. It requires no sterility beyond standard clinical cleaning protocols and is not intended for MRI environments. The device is authorised under FDA 510(k) clearance (K842892) and falls under regulation number 886.3600. No third-party review was involved in its authorisation.
Frequently asked questions
What clinical applications does the Nidek Digital Keratometer support in ophthalmic practice?
The Nidek Digital Keratometer is designed to measure corneal curvature, providing precise readings of corneal radius and refractive power. This data aids in assessing corneal topography and is particularly useful for fitting contact lenses or intraocular lenses, helping clinicians tailor treatments to individual patient needs.
Is the Nidek Digital Keratometer a single-use or reusable device, and what cleaning requirements apply?
The Nidek Digital Keratometer is a reusable instrument intended for use in clinical settings. It does not require sterile packaging beyond standard clinical cleaning protocols, meaning it can be disinfected and reused between patients following routine ophthalmic hygiene practices.
How was the regulatory pathway for this device determined, and what does that mean for its use?
The device was authorized through an FDA 510(k) clearance (K842892) under the traditional review pathway, classified as substantially equivalent to a predicate device. This means it meets FDA standards for safety and effectiveness as determined by comparative analysis, ensuring it can be legally marketed and used in clinical practice as described.
Are there any environmental restrictions on using the Nidek Digital Keratometer, such as MRI compatibility?
The device is explicitly not intended for use in MRI environments. While it is designed for standard ophthalmic diagnostic purposes, its materials or construction may not be safe or compatible with magnetic resonance imaging procedures, so caution should be exercised in facilities where MRI is performed.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K842892 | Class III | Active |
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Manufacturer
- Manufacturer
- Nidek, Inc.
Sources (1)
- FDA 510(k) K842892 24 fields · synced Sep 18, 2026