510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K004005Substantially Equivalent

Mentor Ultrasound-Assisted Tissue Removal System (Current), Mentor Contour Genesis System (Proposed)

Mentor, Santa Barbara CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K004005 is the FDA 510(k) clearance record for MENTOR ULTRASOUND-ASSISTED TISSUE REMOVAL SYSTEM (CURRENT), MENTOR CONTOUR GENESIS SYSTEM (PROPOSED), a class II device, cleared for Mentor Corp. on under FDA product code QPB (System, Suction, Lipoplasty For Removal). FDA's definition for product code QPB reads: "A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring". FDA records list 65 510(k) clearances for Mentor Corp., from to . As of , FDA records show no recalls naming K004005.

Clearance record

Decision date
Received
(290 days to decision)
Product code
QPB System, Suction, Lipoplasty For Removal
Regulation
21 CFR 878.5040
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Mentor Corp. 201 Mentor Dr., Santa Barbara CA
510(k) summary
Summary
Third party review
No

Clearances, product code QPB

Trailing 12 months
5 clearances under product code QPB in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QPB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20261
June 20261
July 20260
August 20261
September 20261
October 20260