Identifiers
- 510(k) Number
- K161972 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 Slit Lamp SL-D301 is a biomicroscope designed for ophthalmic examination. It provides high-resolution imaging of the anterior segment of the eye, including the cornea, iris, lens, and anterior chamber, using a slit beam of light to assess structural details and pathology.
This device is intended for use in clinical settings by trained ophthalmic professionals. Supplied as a reusable instrument, it requires proper cleaning and maintenance to ensure sterility and functionality. The SL-D301 is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance and MDR authorization, adhering to strict manufacturing and performance standards.
Frequently asked questions
Is the Slit Lamp SL-D301 designed for single-use or can it be reused in a clinical setting?
The Slit Lamp SL-D301 is supplied as a reusable instrument. Since it is intended for clinical use by trained ophthalmic professionals, proper cleaning and maintenance are required to ensure sterility and functionality between uses. Reusability is standard for this type of biomicroscope, as it is designed for repeated examinations in professional settings.
What specific parts of the eye can the Slit Lamp SL-D301 examine, and how does it achieve this?
The Slit Lamp SL-D301 is designed to provide high-resolution imaging of the anterior segment of the eye, including the cornea, iris, lens, and anterior chamber. It uses a slit beam of light to illuminate these structures, allowing trained professionals to assess their structural details and identify potential pathology with precision.
How is the Slit Lamp SL-D301 regulated, and what does this mean for its use in clinical settings?
The Slit Lamp SL-D301 is classified as a Class II medical device under FDA regulations and has received FDA 510K clearance, as well as MDR authorization. This means it has undergone rigorous review to ensure safety, performance, and compliance with manufacturing standards before being approved for clinical use in ophthalmic examinations.
What type of power source does the Slit Lamp SL-D301 use, and does this affect its portability?
The Slit Lamp SL-D301 is an AC-powered device, which means it requires a standard electrical outlet for operation. While this setup ensures consistent performance, it may limit its portability compared to battery-powered alternatives, as it cannot be used in locations without direct access to power.
What should clinicians consider when storing the Slit Lamp SL-D301 to maintain its functionality?
Since the SL-D301 is a reusable device, proper storage is essential to preserve its condition and performance. Clinicians should store it in a clean, dry environment away from direct sunlight or extreme temperatures. Regular maintenance, including cleaning and calibration, will also be necessary to ensure accurate imaging and longevity of the device.
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 (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K161972 | Class II | Active |
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Manufacturer
- Manufacturer
- Topcon Corporation
Sources (2)
- FDA 510(k) K161972 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026