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510(k) K182094

Family of Venus RF Systems - Heal by Venus Concept USA, Inc. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2019
Date Received
August 3, 2018
Clearance Type
Special
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.

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  • K220592 — Venus BlissMAX (April 27, 2022)
  • K213308 — Venus BlissMAX (January 12, 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)
  • K142910 — Legacy BX (December 19, 2014)

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