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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 a medical device manufactured by Inmode MD , Ltd.. It received FDA 510(k) clearance on 2019-10-29 under approval 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. It is manufactured by Inmode MD , Ltd.. The 510(k) number is K191855.

When was EmFace Device approved by the FDA?

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

What company makes EmFace Device?

EmFace Device is manufactured by Inmode MD , Ltd..

What is the FDA product code for EmFace Device?

The FDA product code for EmFace Device is PBX.

Other Devices by Inmode MD , Ltd.

K163190InMode RF System K160329InMode System MiniFX Handpiece K153568InMode Plus System K151793InMode RF System K151273InMode FRF Applicator K172302InMode PLUS System

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Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161551TR-100BTL Industries, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, 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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