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FDA 510(k)

Thermi Injectable RF Electrodes

K-Number: K170116 · 2017-03-13

ApplicantThermi
Decision Date2017-03-13
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thermi Injectable RF Electrodes is a medical device manufactured by Thermi. It received FDA 510(k) clearance on 2017-03-13 under approval number K170116. 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 Thermi Injectable RF Electrodes?

Thermi Injectable RF Electrodes is a medical device that received FDA 510(k) clearance on 2017-03-13. It is manufactured by Thermi. The 510(k) number is K170116.

When was Thermi Injectable RF Electrodes approved by the FDA?

Thermi Injectable RF Electrodes received FDA 510(k) clearance on 2017-03-13, under approval number K170116.

What company makes Thermi Injectable RF Electrodes?

Thermi Injectable RF Electrodes is manufactured by Thermi.

What is the FDA product code for Thermi Injectable RF Electrodes?

The FDA product code for Thermi Injectable RF Electrodes is GEI.

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Official Source

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