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FDA 510(k)

CUTERA QSWITCH LASER SYSTEM

K-Number: K102954 · 2011-06-22

ApplicantCutera, Inc.
Decision Date2011-06-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CUTERA QSWITCH LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2011-06-22 under 510(k) number K102954. 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 CUTERA QSWITCH LASER SYSTEM?

CUTERA QSWITCH LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2011-06-22. The listed applicant is Cutera, Inc.. The 510(k) number is K102954.

When did CUTERA QSWITCH LASER SYSTEM receive FDA 510(k) clearance?

CUTERA QSWITCH LASER SYSTEM received FDA 510(k) clearance on 2011-06-22, under 510(k) number K102954.

Who is the listed applicant for CUTERA QSWITCH LASER SYSTEM?

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

What is the FDA product code for CUTERA QSWITCH LASER SYSTEM?

The FDA product code for CUTERA QSWITCH LASER SYSTEM 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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