FDA 510(k)

WAVELIGHT FS200 LASER SYSTEM MODEL: FS200

K-Number: K101006 · 2010-10-21

Decision Date2010-10-21

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Research, Ltd.. It received FDA 510(k) clearance on 2010-10-21 under 510(k) number K101006. 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 LASER SYSTEM MODEL: FS200?

WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 is a medical device that received FDA 510(k) clearance on 2010-10-21. The listed applicant is Alcon Research, Ltd.. The 510(k) number is K101006.

When did WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 receive FDA 510(k) clearance?

WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 received FDA 510(k) clearance on 2010-10-21, under 510(k) number K101006.

Who is the listed applicant for WAVELIGHT FS200 LASER SYSTEM MODEL: FS200?

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

What is the FDA product code for WAVELIGHT FS200 LASER SYSTEM MODEL: FS200?

The FDA product code for WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 is GEX. This falls under the Gastroenterology category.

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Official Source

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