InMode System MiniFX Handpiece
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160329 FDA 510(k)
- FDA Product Code
- PBX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The InMode System MiniFX Handpiece is a Massager, Vacuum, Radio Frequency Induced Heat device, classified as a Class II medical device. It combines non-thermal radiofrequency (RF) energy with mechanical vacuum massage to target the skin and subdermal fat, intended for superficial tissue stimulation and localized circulation enhancement. The device is designed to deliver adjustable RF power and vacuum suction to improve tissue response without thermal damage.
The MiniFX Handpiece is supplied as a reusable component within the InMode System, intended for use in clinical or aesthetic settings by trained professionals. It requires no sterilization between uses but must be cleaned and maintained per manufacturer instructions. The device is not MRI-safe and is regulated under FDA 510(k) clearance (K160329) for general plastic surgery applications. No additional regulatory markings (e.g., CE) are referenced in the data.
Frequently asked questions
What is the InMode MiniFX Handpiece used for?
The InMode MiniFX Handpiece is designed to stimulate superficial tissue and enhance localized circulation through a combination of non-thermal radiofrequency (RF) energy and mechanical vacuum massage. It targets the skin and subdermal fat layers without causing thermal damage, making it suitable for clinical or aesthetic procedures in plastic surgery settings.
Is the MiniFX Handpiece reusable or single-use?
The MiniFX Handpiece is a reusable component within the InMode System. It is intended for repeated use by trained professionals in clinical or aesthetic settings, but it must be cleaned and maintained according to the manufacturer’s instructions to ensure proper functionality and safety.
Does the MiniFX Handpiece require sterilization between uses?
No, the MiniFX Handpiece does not require sterilization between uses. However, it must be thoroughly cleaned and maintained as specified by the manufacturer to prevent contamination and ensure optimal performance. Always follow the provided guidelines to avoid cross-infection risks.
What regulatory approval does the MiniFX Handpiece hold?
The InMode MiniFX Handpiece holds FDA 510(k) clearance (K160329) for general plastic surgery applications. It is classified as a Class II medical device and is intended for use in clinical or aesthetic settings by trained professionals. The device is not MRI-safe.
How is the MiniFX Handpiece supplied and what does it include?
The MiniFX Handpiece is supplied as a reusable component as part of the InMode System. It is designed to be integrated into the system for adjustable RF power and vacuum suction delivery. The handpiece itself does not come as a standalone single-use item but is part of a larger reusable system intended for professional use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: InMode System MiniFX Handpiece (K160329) — FDA 510 (k) | Innolitics, PDF Microsoft Word - K160329 Revised 510(k) Summary 2016-Aug-18, InMode System MiniFX Handpiece — FDA 510 (k) K160329 | MedTracker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160329 | Class II | Active |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA 510(k) K160329 24 fields · synced Oct 1, 2026