DEFINE System (AG612444A)— 510(k) K242598

Substantially Equivalent

InMode , Ltd.

FDA 510(k) clearance K242598 for DEFINE System (AG612444A), Substantially Equivalent on 2024-11-14. Applicant: InMode , Ltd.. Device class: 2.

Clearance details

Applicant: InMode , Ltd.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2024-08-30
Decision date: 2024-11-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Yokneam, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBX

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More clearances from InMode , Ltd.

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K233642 — InMode RF System2024-03-20

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