Cleared Special

K190551 - VASERlipo System

K190551 is an FDA 510(k) clearance for VASERlipo System, manufactured by Solta Medical. The device is a Class 2 General & Plastic Surgery device with product code QPB cleared through the Special 510(k) pathway after a 57-day FDA review.

K190551 · Solta Medical · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2019
Decision
57d
Days
Class 2
Risk

K190551 is an FDA 510(k) clearance for the VASERlipo System. Classified as System, Suction, Lipoplasty For Removal (product code QPB), Class II - Special Controls.

Submitted by Solta Medical (Bothell, US). The FDA issued a Cleared decision on May 1, 2019 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5040 - the FDA general and plastic surgery device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Solta Medical devices

FDA 510(k) Submission Details - K190551

510(k) Number K190551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2019
Decision Date May 01, 2019
Days to Decision 57 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 115d · This submission: 57d
Pathway characteristics
Modification to existing cleared device.

QPB Device Classification - Class 2, Special Controls

Product Code QPB System, Suction, Lipoplasty For Removal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5040
Definition A Suction Lipoplasty System Is A Device Intended For The Removal Of Adipose Tissue For Purposes Of Aesthetic Body Contouring
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Manal Morcos, MS Bme, MBA
Manal Morcos

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QPB System, Suction, Lipoplasty For Removal

All 23
Devices cleared under the same product code (QPB) and FDA review panel - the closest regulatory comparables to K190551.
PAL System
K212024 · Microaire Surgical Instruments, LLC · Jun 2022
PAL Single-Use Cannulas
K192694 · Microaire Surgical Instruments · May 2020
Dermapose Access
K200168 · Puregraft, LLC · Apr 2020
PowerX Lipo System
K190555 · Solta Medical · May 2019
Basic, Dominant Flex, KV-6
K150134 · Medela AG · Apr 2015
MEDELA DOMINANT 50 LIPO, MODEL 600-5706
K063336 · Medela AG · Feb 2007