Peregrine Diffusion Light Pipe
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K950529 FDA 510(k)
- FDA Product Code
- HJM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1945 FDA 510(k)
- Regulation Number
- 886.1945 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Peregrine Diffusion Light Pipe is an ophthalmic transilluminator that provides wide angle illumination during surgical procedures. It is designed to allow surgeons to maintain consistent lighting at all times during ophthalmic and vitreoretinal surgeries. The device features various tip configurations to accommodate different surgical needs.
This device is supplied as a reusable instrument and is not indicated for single-use. It is FDA 510(k) cleared with product code HJM and is classified as a Class II device. The Peregrine Diffusion Light Pipe is manufactured by Peregrine Surgical, Ltd. and is intended for use in ophthalmic surgical settings.
Frequently asked questions
What is the Peregrine Diffusion Light Pipe used for?
The Peregrine Diffusion Light Pipe is an ophthalmic transilluminator designed to provide wide angle illumination during surgical procedures, allowing surgeons to maintain consistent lighting at all times during ophthalmic and vitreoretinal surgeries.
Is the Peregrine Diffusion Light Pipe a single-use device?
No, the Peregrine Diffusion Light Pipe is supplied as a reusable instrument and is not indicated for single-use. It is designed to be sterilized and used multiple times in ophthalmic surgical settings.
What tip configurations are available for the Peregrine Diffusion Light Pipe?
The Peregrine Diffusion Light Pipe features various tip configurations to accommodate different surgical needs, though specific tip models are not detailed in the available information.
What is the regulatory status of the Peregrine Diffusion Light Pipe?
The Peregrine Diffusion Light Pipe is FDA 510(k) cleared with product code HJM and is classified as a Class II device. It received traditional 510(k) clearance on June 7, 1995, with decision code SESE (Substantially Equivalent).
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: Light Pipes — Peregrine Surgical - Ophthalmic and Vitreoretinal ..., Peregrine Surgical - Ophthalmic and Vitreoretinal Surgical Instruments, K950529 FDA 510 (k) - PEREGRINE DIFFUSION LIGHT PIPE, PEREGRINE DIFFUSION LIGHT PIPE (K950529) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950529 | Class II | Active |
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Manufacturer
- Manufacturer
- Peregrine Surgical , Ltd.
Sources (1)
- FDA 510(k) K950529 24 fields · synced Sep 26, 2026