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510(k) K032802

HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III by Hk Surgical, Inc. — Product Code QPB

K032802 is an FDA 510(k) premarket notification submitted by Hk Surgical, Inc. for the device "HK LIPOSUCTION ASPIRATOR, MODEL AP-III & AP230-III". The FDA issued a decision of Substantially Equivalent on November 19, 2003. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Hk Surgical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2003
Date Received
September 9, 2003
Clearance Type
Abbreviated
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 Hk Surgical, Inc.

  • K193664 — SubQKath Catheter and Needle Set (September 9, 2020)
  • K123822 — KLEIN TOUCH PUMP AND DISPOSABLE TUBING SET (September 27, 2013)
  • K031432 — KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II (August 7, 2003)

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