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FDA 510(k)

Evolve System with the T3 Applicator

K-Number: K210877 · 2021-07-19

ApplicantInMode , Ltd.
Decision Date2021-07-19
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Evolve System with the T3 Applicator is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2021-07-19 under 510(k) number K210877. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Evolve System with the T3 Applicator?

Evolve System with the T3 Applicator is a medical device that received FDA 510(k) clearance on 2021-07-19. The listed applicant is InMode , Ltd.. The 510(k) number is K210877.

When did Evolve System with the T3 Applicator receive FDA 510(k) clearance?

Evolve System with the T3 Applicator received FDA 510(k) clearance on 2021-07-19, under 510(k) number K210877.

Who is the listed applicant for Evolve System with the T3 Applicator?

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

What is the FDA product code for Evolve System with the T3 Applicator?

The FDA product code for Evolve System with the T3 Applicator is PBX.

Other records listing InMode , 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: PBX)

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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., Ltd.

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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