FDA 510(k)

Iridex TruFocus LIO Premiere

Número K: K181662 · 2018-09-05

Data da decisão2018-09-05

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Iridex TruFocus LIO Premiere is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2018-09-05 under 510(k) number K181662. 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.

Perguntas frequentes

What is the Iridex TruFocus LIO Premiere?

Iridex TruFocus LIO Premiere is a medical device that received FDA 510(k) clearance on 2018-09-05. The listed applicant is Iridex Corporation. The 510(k) number is K181662.

When did Iridex TruFocus LIO Premiere receive FDA 510(k) clearance?

Iridex TruFocus LIO Premiere received FDA 510(k) clearance on 2018-09-05, under 510(k) number K181662.

Who is the listed applicant for Iridex TruFocus LIO Premiere?

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 TruFocus LIO Premiere?

The FDA product code for Iridex TruFocus LIO Premiere is GEX. This falls under the Gastroenterology category.

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Outros registros que listam Iridex Corporation como candidato(a)

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 K170718Iridex TruFocus LIO Premiere K162416IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

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Fonte oficial

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