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510(k) K170329

Basic, Dominant Flex by Modela AG — Product Code QPB

K170329 is an FDA 510(k) premarket notification submitted by Modela AG for the device "Basic, Dominant Flex". The FDA issued a decision of Substantially Equivalent on March 24, 2017. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2017
Date Received
February 2, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Suction, Lipoplasty For Removal
Device Class
Class II
Regulation Number
878.5040
Review Panel
SU
Submission Type

A suction lipoplasty system is a device intended for the removal of adipose tissue for purposes of aesthetic body contouring

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  • K252495 — LSSA (NP-200) (April 3, 2026)
  • K244050 — AYON Body Contouring System (AYON SYSTEM) (May 12, 2025)
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  • K242804 — PAL Aspiration System (December 30, 2024)
  • K241835 — AirSculpt Body Contouring System (AIRS-1-SYS) (November 27, 2024)
  • K240188 — Vitruvian Liposaber (September 13, 2024)

FDA data resources