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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 the device name listed in this FDA 510(k) record. The listed applicant is Thermi. It received FDA 510(k) clearance on 2017-03-13 under 510(k) 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. The listed applicant is Thermi. The 510(k) number is K170116.

When did Thermi Injectable RF Electrodes receive FDA 510(k) clearance?

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

Who is the listed applicant for Thermi Injectable RF Electrodes?

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

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

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

Other records listing Thermi as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K161661Thermi RF Accessories

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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