Identifiers
- 510(k) Number
- K143123 FDA 510(k)
- FDA Product Code
- MPA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Synergetics Photon Ex is an Endoilluminator, a device used to illuminate the eye during anterior and posterior vitreoretinal surgery. It utilizes a system of lenses and filters, combined with a Xenon bulb to provide high levels of illumination through microfibers. The device is a Class 2 Ophthalmic device with product code MPA.
The Synergetics Photon Ex is supplied as a table-top xenon lamp lightsource for intraocular illumination during vitreoretinal surgery. It is cleared through the Traditional 510(k) pathway with FDA 510(k) clearance number K143123. The device is intended for use in Gastroenterology and Urology medical specialties, although its primary use is in ophthalmic surgery.
Frequently asked questions
What is the Synergetics Photon Ex used for?
The Synergetics Photon Ex is used to illuminate the eye during anterior and posterior vitreoretinal surgery, primarily in ophthalmic surgery.
Is the Synergetics Photon Ex supplied sterile?
The description does not specify if the Synergetics Photon Ex is supplied sterile, but it is intended for use in surgical settings.
What is the regulatory clearance for the Synergetics Photon Ex?
The Synergetics Photon Ex has FDA 510(k) clearance number K143123, cleared through the Traditional 510(k) pathway.
What medical specialties is the Synergetics Photon Ex intended for?
Although its primary use is in ophthalmic surgery, the Synergetics Photon Ex is also intended for use in Gastroenterology and Urology medical specialties.
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: PDF Synergetics-Katalog-gesamt_0416.indd - Whelehan Surgical, K143123 FDA 510 (k) - Synergetics PHOTON EX | Synergetics, Synergetics PHOTON EX (K143123) — 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 | K143123 | Class II | Active |
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Manufacturer
- Manufacturer
- Synergetics, Inc.
- FDA Applicant
- Synergetics
Sources (1)
- FDA 510(k) K143123 24 fields · synced Sep 25, 2026