Iridex TruFocus LIO Premiere

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)

FDA 510(k)

FDA Class 2 ·Ophthalmic

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Iridex 810 Laser

FDA 510(k)

FDA Class 2 ·Ophthalmic

Iridex TruFocus LIO Premiere

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

FDA 510(k)

FDA Class 2 ·Ophthalmic

VARILITE LASER SYSTEM

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

Laser Indirect Ophthalmoscope (LIO)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Iridex Corporation·9 devices

Eye Safety Filter (ESF)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Iridex Corporation·20 devices

Operating Microscope Adapter (OMA)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Iridex Corporation·3 devices

Slit Lamp Adapter (SLA)

Basic UDI-DI

EU MDR · Eu Md Class 1 ·Iridex Corporation·22 devices

Topcon Europe Medical BV

Importer

🇳🇱 Netherlands·2 Manufacturers

Emergo Europe B.V.

Authorized representative

🇳🇱 Netherlands·900 Manufacturers·22100 Devices

Obelis s.a.

Authorized representative

🇧🇪 Belgium·546 Manufacturers·18515 Devices