Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)— 510(k) K151296

Name: FDA 510(k) clearance K151296
Creator: U.S. Food and Drug Administration
Published: 2015-11-19

Substantially Equivalent

Bios S.R.L.

FDA 510(k) clearance K151296 for Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250), Substantially Equivalent on 2015-11-19. Applicant: Bios S.R.L.. Device class: 2.

Clearance details

Applicant: Bios S.R.L.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2015-05-15
Decision date: 2015-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vimodrone, IT

Download summary PDF View on FDA.gov ↗

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Recalls naming K151296

K-number listed on FDA's recall record

Z-0052-2018 — THERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions.Class II·Terminated·Bios S.r.l.·20170713

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151296.

Data sourced from openFDA. This site is unofficial and independent of the FDA.