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510(k) K980763

LYSONIX LIPOPLASTY ACCESS PORT by Lysonix, Inc. — Product Code QPB

K980763 is an FDA 510(k) premarket notification submitted by Lysonix, Inc. for the device "LYSONIX LIPOPLASTY ACCESS PORT". The FDA issued a decision of Substantially Equivalent on May 28, 1998. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Lysonix, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 28, 1998
Date Received
February 27, 1998
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

Other clearances by Lysonix, Inc.

  • K980771 — LYSONIX SUCTION LIPOPLASTY SYSTEM (July 13, 1998)
  • K980454 — LYSONIX ASPIRATION PUMP (March 18, 1998)
  • K974233 — LYSONIX IRRIGATION SYSTEM (February 3, 1998)
  • K972958 — LYSONIX TTD DELTA SCAVENGER SUCTION/ASPIRATION CANNULAS LYSONIX INFUSION DIAMOND (September 19, 1997)

Other clearances for product code QPB

  • K251944 — Lipocosm Harmonic System (June 8, 2026)
  • K253396 — AYON Body Contouring System™ (AYON SYSTEM) (May 8, 2026)
  • K252495 — LSSA (NP-200) (April 3, 2026)
  • K244050 — AYON Body Contouring System (AYON SYSTEM) (May 12, 2025)
  • K244026 — PAL 7020 Console (April 25, 2025)
  • K242804 — PAL Aspiration System (December 30, 2024)
  • K241835 — AirSculpt Body Contouring System (AIRS-1-SYS) (November 27, 2024)
  • K240188 — Vitruvian Liposaber (September 13, 2024)
  • K212969 — Liposaver (August 7, 2024)
  • K220318 — PAL Infiltration System (October 14, 2022)

FDA data resources