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510(k) K981215

PSI-TEC LIPOSUCTION ASPIRATOR by Byron Medical — Product Code QPB

K981215 is an FDA 510(k) premarket notification submitted by Byron Medical for the device "PSI-TEC LIPOSUCTION ASPIRATOR". The FDA issued a decision of Substantially Equivalent on July 1, 1998. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Byron Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1998
Date Received
April 2, 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 Byron Medical

  • K040149 — PSI-TEC PERISTALTIC INFILTRATION PUMP (June 3, 2004)
  • K001803 — ACCELERATOR RECIPROCATING CANNULA (August 4, 2000)
  • K981172 — LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES (June 30, 1998)
  • K980738 — PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILT (June 16, 1998)
  • K980392 — PSI-TEC ASPIRATOR (March 5, 1998)
  • K974295 — BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING (February 10, 1998)
  • K973133 — BIG BAG 3000 PRESSURE INFUSOR (September 12, 1997)
  • K934179 — DISPOSABLE BAG DECANTER (May 23, 1994)
  • K934233 — ZARA ZONE IV MALAR IMPLANT MODIFICATION (February 3, 1994)
  • K933670 — BIOPSY PUNCH, SURGICAL (January 7, 1994)

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