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VASERlipo System

by Solta Medical

510(k) K190551

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK190551 Date1 May 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
QPB
Device class
Class II
Regulation
21 CFR Part 878.5040
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VASERlipo System is a suction, lipoplasty device for removal, classified as a Class II medical device. It uses ultrasound-assisted liposuction technology to target and emulsify fat before suction, designed for use in general and plastic surgery procedures.

The system is supplied by Solta Medical and is intended for single-use or reusable components as specified by the manufacturer. It is FDA 510(k) cleared under K190551 with a substantially equivalent decision, and is regulated under product code QPB. Storage conditions and MRI safety specifications are not detailed in the available data.

Other devices from Solta Medical, Inc.

See all devices from Solta Medical, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VASERlipo System used for?

    The VASERlipo System is a suction, lipoplasty device designed for removal of fat using ultrasound-assisted liposuction technology. It is used in general and plastic surgery procedures to target and emulsify fat before suction.

  • How is the VASERlipo System supplied?

    The system is supplied by Solta Medical and includes components that are either single-use or reusable as specified by the manufacturer. Buyers should confirm component specifications directly with the supplier.

  • Is the VASERlipo System sterile?

    The device data does not specify sterility status. Users must consult the manufacturer's labeling or contact Solta Medical to confirm whether individual components are supplied sterile and the recommended reprocessing for reusable parts.

  • What sizes or models are available?

    The available data lists only the VASERlipo System as a single product name and does not enumerate separate sizes or model variants. For specific component sizes or kit configurations, refer to the manufacturer's product literature.

  • What are the storage requirements?

    Storage conditions for the VASERlipo System are not detailed in the available data. Users should follow the manufacturer's instructions for storage and handling to maintain device integrity.