Home / 510(k) Clearances / K143554

510(k) K143554

Venus Legacy CX by Venus Concept , Ltd. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2015
Date Received
December 15, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Massager, Vacuum, Radio Frequency Induced Heat
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

Other clearances by Venus Concept , Ltd.

  • K252845 — Venus Nova (FP-2001) (November 6, 2025)
  • K232192 — Venus Versa PRO System (September 11, 2023)
  • K162765 — Venus Velocity Diode Laser System (January 11, 2017)
  • K153717 — Venus Versa System (March 21, 2016)
  • K152790 — Venus Versa System (January 20, 2016)
  • K150161 — Venus Viva SR Device (May 12, 2015)
  • K140629 — VENUS SWAN(MP)2 (June 25, 2014)
  • K111670 — VENUS FREEZE (MP)2 SYSTEM (March 2, 2012)
  • K111784 — VENUS SWAN SYSTEM (October 7, 2011)
  • K100586 — VENUS FREEZE SYSTEM (November 29, 2010)

Other clearances for product code PBX

  • K253261 — Apollo Quattro (APQ-10M) (March 13, 2026)
  • K252888 — NeoSculpt Plus (March 9, 2026)
  • K250734 — OptiLUV Device (September 10, 2025)
  • K250916 — WinForth (LM-E470KA) (August 14, 2025)
  • K243716 — Zionic Pro Max (Radiofrequency) (May 28, 2025)
  • K241733 — HEBE (NP0000763) (April 16, 2025)
  • K243055 — Préime DermaFacial Collagen+ (April 15, 2025)
  • K242175 — XOD Diathermia Radiofrequency Device (February 27, 2025)
  • K241107 — Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); I (January 24, 2025)
  • K232966 — FISIOWARM 7.0 (December 26, 2024)