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510(k) K170629

VITRUVIAN INFILTRATION PUMP by Black & Black Surgical, Inc. — Product Code QPB

K170629 is an FDA 510(k) premarket notification submitted by Black & Black Surgical, Inc. for the device "VITRUVIAN INFILTRATION PUMP". The FDA issued a decision of Substantially Equivalent on June 22, 2017. 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
June 22, 2017
Date Received
March 2, 2017
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)
  • K161722 — VITRUVIAN ULTIMATE ASPIRATOR (July 26, 2016)
  • K072124 — BLACK AND BLACK ELECTROSURGICAL CUTTING AND COAGULATION FORCEPS AND ELECTRODES (January 18, 2008)

Other clearances for product code QPB

  • K254135 — LipoSurg ARTIST (September 5, 2026)
  • K261710 — AYON™ Power Liposuction Cannulas and AYON™ Power Liposuction Cannula Adaptors (August 21, 2026)
  • 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)

FDA data resources