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FDA 510(k)

WaveLight FS200 Patient Interface

K-Number: K190392 · 2019-03-26

ApplicantAlcon Laboratories, Inc.
Decision Date2019-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

WaveLight FS200 Patient Interface is a medical device manufactured by Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2019-03-26 under approval 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.

Frequently Asked Questions

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. It is manufactured by Alcon Laboratories, Inc.. The 510(k) number is K190392.

When was WaveLight FS200 Patient Interface approved by the FDA?

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

What company makes WaveLight FS200 Patient Interface?

WaveLight FS200 Patient Interface is manufactured by Alcon Laboratories, Inc..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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