enlighten III Laser System
K-Number: K182997 · 2018-12-12
ApplicantCutera, Inc.
Decision Date2018-12-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
enlighten III Laser System is a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2018-12-12 under approval number K182997. 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 enlighten III Laser System?
enlighten III Laser System is a medical device that received FDA 510(k) clearance on 2018-12-12. It is manufactured by Cutera, Inc.. The 510(k) number is K182997.
When was enlighten III Laser System approved by the FDA?
enlighten III Laser System received FDA 510(k) clearance on 2018-12-12, under approval number K182997.
What company makes enlighten III Laser System?
enlighten III Laser System is manufactured by Cutera, Inc..
What is the FDA product code for enlighten III Laser System?
The FDA product code for enlighten III 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.