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510(k) K201064

V30 System, V20 System, V10 System, V-FR Handpiece by Viora , Ltd. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2020
Date Received
April 21, 2020
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 Viora , Ltd.

  • K202247 — V30 system, V20 system, V10 system, V-VR Hand piece (December 9, 2020)
  • K200468 — V30 system, V20 system, V10 system, V-FC Handpiece (May 21, 2020)
  • K162363 — V30 system, V-Form Handpiece BC Medium applicator (November 18, 2016)
  • K152611 — V20 system (February 19, 2016)
  • K150035 — V10 system (May 1, 2015)
  • K142093 — V20 SYSTEM (November 14, 2014)
  • K141904 — VIORA V-TOUCH (October 21, 2014)
  • K133837 — VIORA V-TOTAL (April 9, 2014)
  • K090221 — REACTION SYSTEM (July 1, 2009)
  • K090399 — TRIOS SYSTEM (June 10, 2009)

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