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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Candela Corporation. It received FDA 510(k) clearance on 2021-12-20 under 510(k) 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. The listed applicant is Candela Corporation. The 510(k) number is K212492.

When did Frax 1940 for Nordlys and Frax Pro receive FDA 510(k) clearance?

Frax 1940 for Nordlys and Frax Pro received FDA 510(k) clearance on 2021-12-20, under 510(k) number K212492.

Who is the listed applicant for Frax 1940 for Nordlys and Frax Pro?

The FDA 510(k) record lists Candela Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

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