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510(k) K161722

VITRUVIAN ULTIMATE ASPIRATOR by Black & Black Surgical, Inc. — Product Code QPB

K161722 is an FDA 510(k) premarket notification submitted by Black & Black Surgical, Inc. for the device "VITRUVIAN ULTIMATE ASPIRATOR". The FDA issued a decision of Substantially Equivalent on July 26, 2016. The device falls under product code QPB (System, Suction, Lipoplasty For Removal), a Class II device regulated under 21 CFR 878.5040. Black & Black Surgical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2016
Date Received
June 22, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

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 Black & Black Surgical, Inc.

  • K240188 — Vitruvian Liposaber (September 13, 2024)
  • K170629 — VITRUVIAN INFILTRATION PUMP (June 22, 2017)
  • K072124 — BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES (January 18, 2008)

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