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FDA 510(k)

Cutera enlighten III Laser System

K-Number: K160488 · 2016-10-28

ApplicantCutera, Inc.
Decision Date2016-10-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Cutera enlighten III 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 2016-10-28 under 510(k) number K160488. 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 enlighten III Laser System?

Cutera enlighten III Laser System is a medical device that received FDA 510(k) clearance on 2016-10-28. The listed applicant is Cutera, Inc.. The 510(k) number is K160488.

When did Cutera enlighten III Laser System receive FDA 510(k) clearance?

Cutera enlighten III Laser System received FDA 510(k) clearance on 2016-10-28, under 510(k) number K160488.

Who is the listed applicant for Cutera enlighten III 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 enlighten III Laser System?

The FDA product code for Cutera enlighten III Laser System is GEX. This falls under the Gastroenterology category.

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Related Devices (Code: GEX)

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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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