Documenting Laser Slit Lamp DP 2010
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012873 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 Documenting Laser Slit Lamp DP 2010 is a biomicroscope, slit-lamp, AC-powered device designed for ophthalmic use. It projects a thin, controlled beam of light to examine the anterior segment of the eye, enabling detailed visualization for diagnostic purposes.
This device is supplied as a reusable, AC-powered instrument intended for clinical settings. It is classified as a Class II medical device under FDA regulation 886.1850 and holds an FDA 510(k) clearance (K012873) with a decision date of November 19, 2001. The device is intended for use by trained ophthalmic professionals and requires proper maintenance and storage as per manufacturer guidelines.
Frequently asked questions
Is the Documenting Laser Slit Lamp DP 2010 designed for single-use or reusable in clinical settings, and what maintenance does it require?
The Documenting Laser Slit Lamp DP 2010 is explicitly supplied as a reusable device for clinical use. Since it is AC-powered and intended for detailed ophthalmic examinations, it requires proper maintenance as outlined by the manufacturer to ensure accuracy, safety, and longevity. Regular cleaning, calibration, and adherence to manufacturer guidelines are essential to sustain performance.
What type of power source does the Documenting Laser Slit Lamp DP 2010 use, and is it suitable for all clinical environments?
The DP 2010 is designed as an AC-powered device, meaning it requires access to standard electrical outlets. While it is intended for clinical settings, its suitability depends on the availability of reliable AC power in the facility. Clinicians should confirm that their environment supports AC-powered equipment before use.
How is the Documenting Laser Slit Lamp DP 2010 regulated, and what does its FDA clearance status indicate?
The DP 2010 holds an FDA 510(k) clearance (K012873), granted under the Traditional 510(k) Review process. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meaning it shares the same intended use and technological characteristics. The clearance was issued on November 19, 2001, and it is classified as a Class II medical device under FDA regulation 886.1850, requiring special controls to ensure safety and effectiveness.
What is the primary purpose of the Documenting Laser Slit Lamp DP 2010, and what part of the eye does it examine?
The DP 2010 is a biomicroscope and slit-lamp designed specifically for ophthalmic use, focusing on the anterior segment of the eye. It projects a thin, controlled beam of light to enable detailed visualization of structures like the cornea, iris, lens, and anterior chamber, aiding in diagnostic evaluations by trained ophthalmic professionals.
Does the Documenting Laser Slit Lamp DP 2010 come with any specific storage or handling instructions, and why are they important?
While the provided data does not explicitly detail storage instructions, as a reusable, AC-powered medical device, the DP 2010 likely requires protection from dust, moisture, and extreme temperatures to prevent damage to its optical and mechanical components. Proper storage ensures longevity, maintains calibration accuracy, and reduces the risk of contamination or malfunction, which is critical for reliable diagnostic performance in clinical settings.
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: DOCUMENTING LASER SLIT LAMP, DP 2010 - Innolitics, DOCUMENTING LASER SLIT LAMP, DP 2010 510(k) K012873 - FDA.report, K992836 FDA 510 (k) - SL990 | Cso
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K012873 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA 510(k) K012873 24 fields · synced Sep 19, 2026