FDA 510(k)

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

N.º K: K162416 · 2016-09-29

Fecha de decisión2016-09-29

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K162416. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Iridex Corporation. The 510(k) number is K162416.

When did IRIDEX Cyclo G6 Laser System, G-Probe Illuminate receive FDA 510(k) clearance?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate received FDA 510(k) clearance on 2016-09-29, under 510(k) number K162416.

Who is the listed applicant for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

The FDA 510(k) record lists Iridex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

The FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is GEX. This falls under the Gastroenterology category.

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Otros registros que enlistan a Iridex Corporation como solicitante

K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)K213592Iridex 810 Laser K202760Iridex 810 Laser K181662Iridex TruFocus LIO Premiere K170718Iridex TruFocus LIO Premiere

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Fuente oficial

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