Gemini 810+980 Soft Tissue Laser
K-Number: K192617 · 2020-02-20
ApplicantAzena Medical, LLC
Decision Date2020-02-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Gemini 810+980 Soft Tissue Laser is a medical device manufactured by Azena Medical, LLC. It received FDA 510(k) clearance on 2020-02-20 under approval number K192617. 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 Gemini 810+980 Soft Tissue Laser?
Gemini 810+980 Soft Tissue Laser is a medical device that received FDA 510(k) clearance on 2020-02-20. It is manufactured by Azena Medical, LLC. The 510(k) number is K192617.
When was Gemini 810+980 Soft Tissue Laser approved by the FDA?
Gemini 810+980 Soft Tissue Laser received FDA 510(k) clearance on 2020-02-20, under approval number K192617.
What company makes Gemini 810+980 Soft Tissue Laser?
Gemini 810+980 Soft Tissue Laser is manufactured by Azena Medical, LLC.
What is the FDA product code for Gemini 810+980 Soft Tissue Laser?
The FDA product code for Gemini 810+980 Soft Tissue 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.