FDA 510(k)

WaveLight FS200 Patient Interface

Número K: K190392 · 2019-03-26

Data da decisão2019-03-26

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

WaveLight FS200 Patient Interface is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2019-03-26 under 510(k) number K190392. 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 WaveLight FS200 Patient Interface?

WaveLight FS200 Patient Interface is a medical device that received FDA 510(k) clearance on 2019-03-26. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K190392.

When did WaveLight FS200 Patient Interface receive FDA 510(k) clearance?

WaveLight FS200 Patient Interface received FDA 510(k) clearance on 2019-03-26, under 510(k) number K190392.

Who is the listed applicant for WaveLight FS200 Patient Interface?

The FDA 510(k) record lists Alcon Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WaveLight FS200 Patient Interface?

The FDA product code for WaveLight FS200 Patient Interface is GEX. This falls under the Gastroenterology category.

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Fonte oficial

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