UltraLight LED System
K-Number: K210535 · 2021-05-24
ApplicantRohrer Aesthetics, LLC
Decision Date2021-05-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
UltraLight LED System is a medical device manufactured by Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2021-05-24 under approval number K210535. 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 UltraLight LED System?
UltraLight LED System is a medical device that received FDA 510(k) clearance on 2021-05-24. It is manufactured by Rohrer Aesthetics, LLC. The 510(k) number is K210535.
When was UltraLight LED System approved by the FDA?
UltraLight LED System received FDA 510(k) clearance on 2021-05-24, under approval number K210535.
What company makes UltraLight LED System?
UltraLight LED System is manufactured by Rohrer Aesthetics, LLC.
What is the FDA product code for UltraLight LED System?
The FDA product code for UltraLight LED 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.