SOUND SURGICAL VASER 2.1 LIPO SYSTEM— 510(k) K110306

Name: FDA 510(k) clearance K110306
Creator: U.S. Food and Drug Administration
Published: 2011-06-23

Substantially Equivalent

Sound Surgical Technologies, LLC

FDA 510(k) clearance K110306 for SOUND SURGICAL VASER 2.1 LIPO SYSTEM, Substantially Equivalent on 2011-06-23. Applicant: Sound Surgical Technologies, LLC. Device class: 2.

Clearance details

Applicant: Sound Surgical Technologies, LLC
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2011-02-02
Decision date: 2011-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, CO, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110306

K-number listed on FDA's recall record

Z-3047-2017 — VASER Amplifier, VASER 2.2 VASERlipo System, Rx Only, 115/230V - 60/50Hz 300VA The Vaser amplifier is intended for the fragmentation and emulsification of subcutaneous fatty tissues for aesthetic body contouring (modification of the anatomy).Class II·Terminated·Solta Medical Inc·20170601

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110306.

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