Frax 1940 for Nordlys and Frax Pro
K-Number: K212492 · 2021-12-20
ApplicantCandela Corporation
Decision Date2021-12-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Frax 1940 for Nordlys and Frax Pro is a medical device manufactured by Candela Corporation. It received FDA 510(k) clearance on 2021-12-20 under approval number K212492. 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 Frax 1940 for Nordlys and Frax Pro?
Frax 1940 for Nordlys and Frax Pro is a medical device that received FDA 510(k) clearance on 2021-12-20. It is manufactured by Candela Corporation. The 510(k) number is K212492.
When was Frax 1940 for Nordlys and Frax Pro approved by the FDA?
Frax 1940 for Nordlys and Frax Pro received FDA 510(k) clearance on 2021-12-20, under approval number K212492.
What company makes Frax 1940 for Nordlys and Frax Pro?
Frax 1940 for Nordlys and Frax Pro is manufactured by Candela Corporation.
What is the FDA product code for Frax 1940 for Nordlys and Frax Pro?
The FDA product code for Frax 1940 for Nordlys and Frax Pro 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.