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510(k) K151296

Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250) by Bios S.R.L. — Product Code PBX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2015
Date Received
May 15, 2015
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.

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  • K230755 — NuEra Tight RF Model OptiStream (October 30, 2023)
  • K223856 — NuEra Tight RF Family (August 11, 2023)
  • K223907 — NuEra Tight RF Model APMD145.M70-US (May 2, 2023)
  • K210867 — NuEra Tight RF, NuEra Tight RF Plus (April 21, 2021)
  • K201239 — NuEra Tight Family, EMS Model (December 31, 2020)
  • K200359 — NuEra Tight, NuEra Tight EMS (August 11, 2020)
  • K161632 — FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) (December 8, 2016)
  • K153229 — Superbium (April 12, 2016)

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  • K250916 — WinForth (LM-E470KA) (August 14, 2025)
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  • 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)