Ophthalmed Bending Laser Probes
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142830 FDA 510(k)
- FDA Product Code
- HQF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4390 FDA 510(k)
- Regulation Number
- 886.4390 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ophthalmed Bending Laser Probes are Laser, Ophthalmic devices designed for precise laser applications in eye surgery. These probes deliver controlled laser energy to perform procedures such as photocoagulation, photodisruption, or tissue ablation in ophthalmic treatments, including retinal surgeries and corneal procedures.
These probes are supplied as single-use, sterile instruments and are classified as Class II medical devices under FDA regulations. They are intended for use in clinical settings with appropriate laser systems and are regulated under FDA 510(k) clearance and MDD (Medical Device Directive) compliance. Multiple probe configurations are available, each tailored for specific surgical needs, and must be stored in accordance with manufacturer instructions to maintain sterility and functionality.
Frequently asked questions
Are these laser probes reusable or single-use, and how should they be handled to maintain sterility?
The Ophthalmed Bending Laser Probes are designed for single-use only to ensure patient safety and sterility. They are supplied sterile, so they must remain unopened until immediately before use. After opening, they should be handled with sterile technique and used only once. Any unused portion must be discarded according to facility protocols for single-use devices.
What types of eye surgeries or procedures are these probes intended to assist with?
These probes are specifically designed for ophthalmic laser applications, including procedures like photocoagulation, photodisruption, or tissue ablation. They are commonly used in surgeries involving the retina or cornea, such as retinal treatments or corneal reshaping procedures, where precise laser energy delivery is required.
Do these probes come in different sizes or configurations, and how do I know which one to select?
Yes, the Ophthalmed Bending Laser Probes are available in multiple configurations, each tailored for specific surgical needs. The exact models and their intended applications are listed in the manufacturer’s documentation, which should guide selection based on the procedure (e.g., retinal vs. corneal work). Always refer to the provided instructions to ensure compatibility with your laser system and surgical requirements.
How should these probes be stored to preserve their functionality and sterility?
To maintain sterility and functionality, these probes must be stored in their original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions for storage conditions, which typically include keeping them upright and protected from contamination until use.
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
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K142830 | Class II | Active |
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Manufacturer
- Manufacturer
- Ophthalmed Llc
- FDA Applicant
- Ophthalmed, LLC
Sources (2)
- FDA 510(k) K142830 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026