Identifiers
- 510(k) Number
- K081756 FDA 510(k)
- FDA Product Code
- HKX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ocular Response Analyzer G3 is an ophthalmic diagnostic device classified as a tonometer, ac-powered. It measures corneal hysteresis and corneal-compensated intraocular pressure (IOPcc) to assess ocular biomechanics, aiding in the evaluation of glaucoma progression and risk stratification.
This device is supplied as a reusable, non-sterile diagnostic instrument intended for use in clinical ophthalmology settings. It operates under FDA 510(k) clearance (K081756) as substantially equivalent to predicate devices, adhering to regulatory standards for Class II medical devices (886.1930). No MRI safety information or specific sterility requirements are noted in the specifications.
Frequently asked questions
What is the Ocular Response Analyzer G3 used for?
The Reichert Ocular Response Analyzer G3 is an ophthalmic diagnostic device designed to measure corneal hysteresis and corneal-compensated intraocular pressure (IOPcc). These measurements help assess ocular biomechanics, which is particularly useful in evaluating glaucoma progression and risk stratification. By providing insights into the mechanical properties of the cornea, it aids clinicians in making more informed decisions about patient care.
Is the Ocular Response Analyzer G3 reusable or single-use?
The Ocular Response Analyzer G3 is supplied as a reusable device. It is intended for use in clinical ophthalmology settings and is not designed for single-use. Reusability is typical for diagnostic instruments like this, provided they are properly cleaned and maintained according to manufacturer guidelines to ensure accuracy and safety.
What are the sterility and cleaning requirements for this device?
The Ocular Response Analyzer G3 is classified as a non-sterile diagnostic instrument. Since it is reusable, it must be cleaned and maintained according to the manufacturer’s instructions to prevent contamination and ensure reliable performance. There are no specific sterility requirements noted in the specifications, but standard clinical disinfection protocols should be followed to maintain hygiene and functionality.
Does the Ocular Response Analyzer G3 have any special storage instructions?
While the provided specifications do not explicitly detail storage instructions, reusable medical devices like the Ocular Response Analyzer G3 generally require protection from dust, moisture, and extreme temperatures. It should be stored in a clean, dry environment, away from direct sunlight or sources of electromagnetic interference, to preserve its accuracy and operational integrity. Always refer to the manufacturer’s guidelines for specific storage recommendations.
What regulatory clearance does the Ocular Response Analyzer G3 hold?
The Ocular Response Analyzer G3 holds FDA 510(k) clearance under the reference number K081756. This clearance indicates that the device is deemed substantially equivalent to a predicate device and meets the regulatory standards for Class II medical devices under the classification code 886.1930. The clearance was granted by the FDA’s Ophthalmic Devices Panel (OP) in 2008.
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: Ocular Response Analyzer®G3 | Measures Corneal Hysteresis ... - Reichert, Reichert® Ocular Response Analyzer® G3, Reichert Ocular Response Analyzer® G3 - OPTIMETRICS, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K081756 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Reichert, Inc.
Sources (1)
- FDA 510(k) K081756 24 fields · synced Oct 1, 2026