EmoLED (v. 2-USA)
K-Number: K240132 · 2024-03-12
ApplicantEmoled, Srl
Decision Date2024-03-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
EmoLED (v. 2-USA) is a medical device manufactured by Emoled, Srl. It received FDA 510(k) clearance on 2024-03-12 under approval number K240132. 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 EmoLED (v. 2-USA)?
EmoLED (v. 2-USA) is a medical device that received FDA 510(k) clearance on 2024-03-12. It is manufactured by Emoled, Srl. The 510(k) number is K240132.
When was EmoLED (v. 2-USA) approved by the FDA?
EmoLED (v. 2-USA) received FDA 510(k) clearance on 2024-03-12, under approval number K240132.
What company makes EmoLED (v. 2-USA)?
EmoLED (v. 2-USA) is manufactured by Emoled, Srl.
What is the FDA product code for EmoLED (v. 2-USA)?
The FDA product code for EmoLED (v. 2-USA) 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.