Accure Laser
K-Number: K222109 · 2022-11-17
ApplicantAccure Acne, Inc.
Decision Date2022-11-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Accure Laser is a medical device manufactured by Accure Acne, Inc.. It received FDA 510(k) clearance on 2022-11-17 under approval number K222109. 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?
Accure Laser is a medical device that received FDA 510(k) clearance on 2022-11-17. It is manufactured by Accure Acne, Inc.. The 510(k) number is K222109.
When was Accure Laser approved by the FDA?
Accure Laser received FDA 510(k) clearance on 2022-11-17, under approval number K222109.
What company makes Accure Laser?
Accure Laser is manufactured by Accure Acne, Inc..
What is the FDA product code for Accure Laser?
The FDA product code for Accure Laser 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.