Family of CoolGlide Aesthetic Lasers
K-Number: K153671 · 2016-03-09
ApplicantCutera, Inc.
Decision Date2016-03-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Family of CoolGlide Aesthetic Lasers is a medical device manufactured by Cutera, Inc.. It received FDA 510(k) clearance on 2016-03-09 under approval number K153671. 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 Family of CoolGlide Aesthetic Lasers?
Family of CoolGlide Aesthetic Lasers is a medical device that received FDA 510(k) clearance on 2016-03-09. It is manufactured by Cutera, Inc.. The 510(k) number is K153671.
When was Family of CoolGlide Aesthetic Lasers approved by the FDA?
Family of CoolGlide Aesthetic Lasers received FDA 510(k) clearance on 2016-03-09, under approval number K153671.
What company makes Family of CoolGlide Aesthetic Lasers?
Family of CoolGlide Aesthetic Lasers is manufactured by Cutera, Inc..
What is the FDA product code for Family of CoolGlide Aesthetic Lasers?
The FDA product code for Family of CoolGlide Aesthetic Lasers 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.