Identifiers
- 510(k) Number
- K141954 FDA 510(k)
- FDA Product Code
- HJO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1850 FDA 510(k)
- Regulation Number
- 886.1850 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Xcel 455 Slit Lamp is a biomicroscope, slit-lamp, AC-powered device used for ophthalmic examination. It is substantially equivalent to a legally marketed device and received FDA 510(k) clearance under K141954.
It is supplied as a reusable, AC-powered instrument intended for use in clinical settings such as ophthalmology offices or clinics. The device is not sterile, not single-use, and has no stated MRI safety information. Storage and handling should follow manufacturer guidelines as outlined in the user manual.
Frequently asked questions
What is the XCEL 455 Slit Lamp used for?
The XCEL 455 Slit Lamp is a biomicroscope used for ophthalmic examination, allowing clinicians to view anterior eye structures in detail during clinical assessments in ophthalmology offices or clinics.
Is the XCEL 455 Slit Lamp sterile or single-use?
The XCEL 455 Slit Lamp is supplied as a non-sterile, reusable instrument; it is not designed for single-use and must be cleaned and maintained according to the manufacturer’s guidelines between uses.
How is the XCEL 455 Slit Lamp powered and where is it intended for use?
The XCEL 455 Slit Lamp is AC-powered and intended for use in clinical settings such as ophthalmology offices or clinics, where it supports routine eye examinations requiring slit-lamp biomicroscopy.
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: Xcel® 455 Slit Lamp lenses | Digital slit lamp - Reichert, REICHERT XCEL 455 USER MANUAL Pdf Download | ManualsLib, Reichert Xcel 455 Slit Lamp User's Guide - Manualzz, Reichert XCEL 455 Manuals | ManualsLib
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141954 | Class II | Active |
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Manufacturer
- Manufacturer
- Reichert, Inc.
Sources (1)
- FDA 510(k) K141954 24 fields · synced Sep 24, 2026