Accure Laser System
K-Number: K242035 · 2024-10-11
ApplicantAccure Acne, Inc.
Decision Date2024-10-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Accure Laser System is a medical device manufactured by Accure Acne, Inc.. It received FDA 510(k) clearance on 2024-10-11 under approval number K242035. 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 Accure Laser System?
Accure Laser System is a medical device that received FDA 510(k) clearance on 2024-10-11. It is manufactured by Accure Acne, Inc.. The 510(k) number is K242035.
When was Accure Laser System approved by the FDA?
Accure Laser System received FDA 510(k) clearance on 2024-10-11, under approval number K242035.
What company makes Accure Laser System?
Accure Laser System is manufactured by Accure Acne, Inc..
What is the FDA product code for Accure Laser System?
The FDA product code for Accure 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.