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FDA 510(k)

PowerX Lipo System

K-Number: K190555 · 2019-05-01

ApplicantSolta Medical
Decision Date2019-05-01
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PowerX Lipo System is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical. It received FDA 510(k) clearance on 2019-05-01 under 510(k) number K190555. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PowerX Lipo System?

PowerX Lipo System is a medical device that received FDA 510(k) clearance on 2019-05-01. The listed applicant is Solta Medical. The 510(k) number is K190555.

When did PowerX Lipo System receive FDA 510(k) clearance?

PowerX Lipo System received FDA 510(k) clearance on 2019-05-01, under 510(k) number K190555.

Who is the listed applicant for PowerX Lipo System?

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

What is the FDA product code for PowerX Lipo System?

The FDA product code for PowerX Lipo System is QPB.

Other records listing Solta Medical 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.

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Related Devices (Code: QPB)

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.

K251944Lipocosm Harmonic SystemLipocosm, LLCK253396AYON Body Contouring System™ (AYON SYSTEM)Apyx Medical CorporationK252495LSSA (NP-200)Newpong Co., Ltd.K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical CorporationK244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLCK242804PAL Aspiration SystemMicroaire Surgical Instruments, LLC

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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