Profound Matrix
K-Number: K211217 · 2021-12-16
ApplicantCandela Corporation
Decision Date2021-12-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Profound Matrix is a medical device manufactured by Candela Corporation. It received FDA 510(k) clearance on 2021-12-16 under approval number K211217. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Profound Matrix?
Profound Matrix is a medical device that received FDA 510(k) clearance on 2021-12-16. It is manufactured by Candela Corporation. The 510(k) number is K211217.
When was Profound Matrix approved by the FDA?
Profound Matrix received FDA 510(k) clearance on 2021-12-16, under approval number K211217.
What company makes Profound Matrix?
Profound Matrix is manufactured by Candela Corporation.
What is the FDA product code for Profound Matrix?
The FDA product code for Profound Matrix is GEI.
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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.