PowerX Lipo System— 510(k) K190555

Substantially Equivalent

Solta Medical

FDA 510(k) clearance K190555 for PowerX Lipo System, Substantially Equivalent on 2019-05-01. Applicant: Solta Medical. Device class: 2.

Clearance details

Applicant: Solta Medical
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2019-03-05
Decision date: 2019-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Bothell, WA, US

Download summary PDF View on FDA.gov ↗

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