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FDA 510(k)

InMode FRF Applicator

K-Number: K151273 · 2016-01-04

Decision Date2016-01-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode FRF Applicator is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2016-01-04 under 510(k) number K151273. 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 InMode FRF Applicator?

InMode FRF Applicator is a medical device that received FDA 510(k) clearance on 2016-01-04. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K151273.

When did InMode FRF Applicator receive FDA 510(k) clearance?

InMode FRF Applicator received FDA 510(k) clearance on 2016-01-04, under 510(k) number K151273.

Who is the listed applicant for InMode FRF Applicator?

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

What is the FDA product code for InMode FRF Applicator?

The FDA product code for InMode FRF Applicator is GEI.

Related Clinical Trials

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.

Other records listing Inmode MD , Ltd. 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.

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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.

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.