DermaV Laser System
K-Number: K203788 · 2021-03-26
ApplicantLutronic Corporation
Decision Date2021-03-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
DermaV Laser System is a medical device manufactured by Lutronic Corporation. It received FDA 510(k) clearance on 2021-03-26 under approval number K203788. 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 DermaV Laser System?
DermaV Laser System is a medical device that received FDA 510(k) clearance on 2021-03-26. It is manufactured by Lutronic Corporation. The 510(k) number is K203788.
When was DermaV Laser System approved by the FDA?
DermaV Laser System received FDA 510(k) clearance on 2021-03-26, under approval number K203788.
What company makes DermaV Laser System?
DermaV Laser System is manufactured by Lutronic Corporation.
What is the FDA product code for DermaV Laser System?
The FDA product code for DermaV 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.