InMode RF Pro System— 510(k) K210492

Name: FDA 510(k) clearance K210492
Creator: U.S. Food and Drug Administration
Published: 2021-07-12

Substantially Equivalent

Inmode MD , Ltd.

FDA 510(k) clearance K210492 for InMode RF Pro System, Substantially Equivalent on 2021-07-12. Applicant: Inmode MD , Ltd.. Device class: 2.

Clearance details

Applicant: Inmode MD , Ltd.
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2021-02-19
Decision date: 2021-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

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More clearances from Inmode MD , Ltd.

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K192695 — InMode System with the Morpheus8 (Fractora) Applicators2019-12-27
K191855 — EmFace Device2019-10-29
K183450 — EmBody System2019-06-20
K182325 — InMode RF System2018-09-26
K180719 — InMode Diolaze System2018-06-14

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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