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510(k) K213308

Venus BlissMAX by Venus Concept USA, Inc. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2022
Date Received
October 4, 2021
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 USA, Inc.

  • K221011 — AI.ME System (December 20, 2022)
  • K220592 — Venus BlissMAX (April 27, 2022)
  • K211461 — Family of Venus RF Systems - Venus Freedom (October 14, 2021)
  • K201164 — Venus Viva MD Device (June 26, 2020)
  • K200786 — Venus Epileve (June 9, 2020)
  • K191065 — Venus VivaTM (April 1, 2020)
  • K191528 — Venus Legacy Pro Device (September 6, 2019)
  • K190743 — Venus Bliss (June 25, 2019)
  • K182094 — Family of Venus RF Systems - Heal (February 1, 2019)
  • K142910 — Legacy BX (December 19, 2014)

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  • 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)