Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1
FDA 510(k)Class II (US FDA 510(k))
by Iridex Corp
Identifiers
- 510(k) Number
- K060905 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Iridex Otoprobe Long and Short Angles (P/N 14310-1 and 14320-1) is a sterile, single-use laser energy delivery accessory designed for otologic procedures. It features a glass fiber optic protected by a stainless steel needle/handle at the distal end and a plastic jacket at the proximal end, enabling precise laser application. The device attaches to the IRIDEX OcuLight or compatible 532 nm laser systems via a universal SMA connector. Available in two configurations—short-angle for enhanced visibility of tissue around the needle tip and long-angle for extended reach—the Otoprobe facilitates targeted laser delivery in otological surgeries.
The Otoprobe is intended for single-use in sterile surgical settings and requires compatibility with 532 nm laser systems. Supplied sterile, it is designed for otologic procedures and adheres to FDA 510(k) clearance under the General, Plastic Surgery advisory committee (K060905). The device is not reusable and must be stored in accordance with manufacturer guidelines to maintain sterility and functionality. No additional regulatory markings beyond the stated FDA clearance are provided in the specifications.
Frequently asked questions
What are the Iridex Otoprobe Long and Short Angles (P/N 14310-1 and 14320-1) used for?
These Otoprobes are designed specifically for otologic (ear) surgeries. The short-angle model (P/N 14310-1) provides enhanced visibility of tissue around the needle tip, while the long-angle model (P/N 14320-1) offers extended reach for targeted laser delivery. Both are intended to attach to IRIDEX OcuLight or compatible 532 nm laser systems, ensuring precise and controlled laser energy application during procedures.
Are the Iridex Otoprobe Long and Short Angles reusable or single-use?
The Iridex Otoprobe Long and Short Angles are strictly single-use devices. They are supplied sterile and intended for one-time use in sterile surgical settings to maintain safety and sterility standards. Reuse is not recommended or supported by the manufacturer.
How do I attach the Otoprobe to a laser system?
The Otoprobe connects to the IRIDEX OcuLight or compatible 532 nm laser systems via a universal SMA connector located at the proximal end of the device. The design ensures compatibility with these systems, allowing for precise laser energy delivery during otologic procedures.
What are the key differences between the short-angle and long-angle Otoprobes?
The short-angle Otoprobe (P/N 14310-1) is designed with a configuration that improves visibility of the tissue surrounding the needle tip, making it ideal for procedures requiring close, detailed laser application. The long-angle Otoprobe (P/N 14320-1) features an extended reach, allowing for deeper or more distant laser delivery in the ear canal, depending on the surgical needs.
How should the Otoprobe be stored to maintain sterility and functionality?
The Otoprobe must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, it should be kept in its original packaging until use. Avoid exposure to moisture, extreme temperatures, or contamination, as these factors could compromise the device’s integrity.
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: Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1 (K060905 ..., PDF out 1 - IRIDEX, About Us - Iridex Corporation, fda.innolitics.com, PDF OtoProbe (Final).qxp
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060905 | Class II | Active |
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Manufacturer
- Manufacturer
- Iridex Corp
Sources (1)
- FDA 510(k) K060905 24 fields · synced Oct 1, 2026