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510(k) K980763

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

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)

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