New Era
K-Number: K182604 · 2018-11-14
ApplicantStep UP Skin Laser, LLC
Decision Date2018-11-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
New Era is a medical device manufactured by Step UP Skin Laser, LLC. It received FDA 510(k) clearance on 2018-11-14 under approval number K182604. 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 New Era?
New Era is a medical device that received FDA 510(k) clearance on 2018-11-14. It is manufactured by Step UP Skin Laser, LLC. The 510(k) number is K182604.
When was New Era approved by the FDA?
New Era received FDA 510(k) clearance on 2018-11-14, under approval number K182604.
What company makes New Era?
New Era is manufactured by Step UP Skin Laser, LLC.
What is the FDA product code for New Era?
The FDA product code for New Era 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.