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Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)

by Bios S.R.L.

510(k) K151296

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK151296 Date19 Nov 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0052-2018 FDA Class II initiated 13 Jul 2017

    In some systems, the unit continues to emit RF energy after the PAUSE button is pressed.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
PBX
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Family of Radiofrequency System, including the Biorevital RF MED and ThermiSmooth 250 models, is a radio frequency induced heat device. It is designed to provide heating to elevate tissue temperature for the temporary relief of pain, the reduction of muscle spasms, and the increase of local circulation.

This device is classified as a massager under regulation number 878.4400. It is identified under FDA 510(k) number K151296 and is manufactured by Bios S.R.L.

Other devices from Bios S.R.L.

See all devices from Bios S.R.L. →

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary clinical purpose of the Family of Radiofrequency System?

    This device is designed to provide radio frequency induced heat to elevate tissue temperature. This process is intended for the temporary relief of pain, the reduction of muscle spasms, and the increase of local circulation.

  • Which specific models are included in this system?

    The Family of Radiofrequency System includes the Biorevital RF MED and the ThermiSmooth 250 models.

  • How is this device classified for regulatory purposes?

    The system is classified as a massager under regulation number 878.4400. It is identified under FDA 510(k) number K151296 and is manufactured by Bios S.R.L.