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FDA 510(k)

InMode System MiniFX Handpiece

K-Number: K160329 · 2016-08-19

ApplicantInmode MD , Ltd.
Decision Date2016-08-19
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

InMode System MiniFX Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K160329. 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 InMode System MiniFX Handpiece?

InMode System MiniFX Handpiece is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K160329.

When did InMode System MiniFX Handpiece receive FDA 510(k) clearance?

InMode System MiniFX Handpiece received FDA 510(k) clearance on 2016-08-19, under 510(k) number K160329.

Who is the listed applicant for InMode System MiniFX Handpiece?

The FDA 510(k) record lists Inmode MD , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for InMode System MiniFX Handpiece?

The FDA product code for InMode System MiniFX Handpiece is PBX.

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Other records listing Inmode MD , Ltd. as applicant

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Related Devices (Code: PBX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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