EmFace Device— 510(k) K191855

Substantially Equivalent

Inmode MD , Ltd.

FDA 510(k) clearance K191855 for EmFace Device, Substantially Equivalent on 2019-10-29. Applicant: Inmode MD , Ltd.. Device class: 2.

Clearance details

Applicant: Inmode MD , Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2019-07-10
Decision date: 2019-10-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

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K253261 — Apollo Quattro (APQ-10M)2026-03-13
K252888 — NeoSculpt Plus2026-03-09
K250734 — OptiLUV Device2025-09-10

More clearances from Inmode MD , Ltd.

K210492 — InMode RF Pro System2021-07-12
K192695 — InMode System with the Morpheus8 (Fractora) Applicators2019-12-27
K183450 — EmBody System2019-06-20
K182325 — InMode RF System2018-09-26
K180719 — InMode Diolaze System2018-06-14

Data sourced from openFDA. This site is unofficial and independent of the FDA.