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FDA 510(k)

EmFace Device

K-Number: K191855 · 2019-10-29

ApplicantInmode MD , Ltd.
Decision Date2019-10-29
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EmFace Device 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 2019-10-29 under 510(k) number K191855. 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 EmFace Device?

EmFace Device is a medical device that received FDA 510(k) clearance on 2019-10-29. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K191855.

When did EmFace Device receive FDA 510(k) clearance?

EmFace Device received FDA 510(k) clearance on 2019-10-29, under 510(k) number K191855.

Who is the listed applicant for EmFace Device?

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 EmFace Device?

The FDA product code for EmFace Device is PBX.

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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.

K210492InMode RF Pro SystemK192695InMode System with the Morpheus8 (Fractora) ApplicatorsK183450EmBody SystemK182325InMode RF SystemK180719InMode Diolaze SystemK180189InMode System with Fractora3D/3D-90 Applicators

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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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