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FDA 510(k)

Lipogems System

K-Number: K161636 · 2016-11-04

ApplicantLipogems International Spa
Decision Date2016-11-04
Product CodeMUU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Lipogems System is the device name listed in this FDA 510(k) record. The listed applicant is Lipogems International Spa. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161636. The device is classified under product code MUU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lipogems System?

Lipogems System is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Lipogems International Spa. The 510(k) number is K161636.

When did Lipogems System receive FDA 510(k) clearance?

Lipogems System received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161636.

Who is the listed applicant for Lipogems System?

The FDA 510(k) record lists Lipogems International Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lipogems System?

The FDA product code for Lipogems System is MUU.

Other records listing Lipogems International Spa as applicant

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.

K171135Lipogems System

Related Devices (Code: MUU)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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