Identifiers
- 510(k) Number
- K061330 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 PSL Portable Slit Lamp is a handheld biomicroscope designed for ophthalmic examination. It provides high-magnification illumination and imaging of the anterior segment of the eye, including the cornea, iris, lens, and anterior chamber, enabling detailed assessment of ocular structures.
This portable device is powered by AC and features a lightweight, compact design for use in clinical or field settings. It is intended for single-use or reusable applications, depending on manufacturer guidelines, and has received FDA 510(k) clearance under the Ophthalmic advisory committee. The device is classified as Class II and adheres to regulatory standards outlined in 21 CFR 886.1850.
Frequently asked questions
What is the Reichert PSL Portable Slit Lamp used for?
The Reichert PSL Portable Slit Lamp is a handheld biomicroscope designed specifically for detailed ophthalmic examinations. It provides high-magnification illumination and imaging of the anterior segment of the eye, including the cornea, iris, lens, and anterior chamber. This allows clinicians to assess ocular structures with precision, making it ideal for diagnosing and monitoring conditions affecting these areas.
How is the PSL Portable Slit Lamp powered and what is its design like?
The PSL Portable Slit Lamp is powered by AC electricity, ensuring reliable performance in clinical settings. Its design is lightweight and compact, making it highly portable for use in both clinical and field environments. This portability allows for greater flexibility in patient examinations without compromising the quality of imaging.
Is the Reichert PSL Portable Slit Lamp intended for single-use or reusable applications?
The PSL Portable Slit Lamp can be used for either single-use or reusable applications, depending on the manufacturer’s guidelines. Proper cleaning, disinfection, and maintenance procedures must be followed if the device is intended for reuse to ensure sterility and functionality. Always refer to the manufacturer’s instructions for specific usage recommendations.
What regulatory approval does the PSL Portable Slit Lamp hold?
The Reichert PSL Portable Slit Lamp has received FDA 510(k) clearance under the Ophthalmic advisory committee. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and adheres to regulatory standards outlined in 21 CFR 886.1850. It is categorized as a Class II medical device.
What are the key specifications or features that distinguish this slit lamp?
The PSL Portable Slit Lamp is distinguished by its handheld design, which enables portability without sacrificing the high-magnification imaging capabilities required for anterior segment examinations. It is AC-powered, ensuring consistent performance, and is designed for use in diverse settings, including clinical and field environments. The device’s compact form factor also makes it easier to maneuver during examinations.
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: Discontinued PSL Portable Slit Lamp - Reichert, AMETEK REICHERT PSL USER MANUAL Pdf Download | ManualsLib, Reichert Slit Lamp PSL - Dan Scott and Associates, Operating Instructions. Reichert PSL - Manualzz
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061330 | Class II | Active |
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Manufacturer
- Manufacturer
- Reichert, Inc.
Sources (1)
- FDA 510(k) K061330 24 fields · synced Oct 1, 2026