Bios S.r.l.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
15
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0052-2018Class IITHERMI250 Radiofrequency System. Intended to provide heating for the purpose of elevating tissue July 13, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K243445Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)December 30, 2024
K241407Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)June 14, 2024
K230755NuEra Tight RF Model OptiStreamOctober 30, 2023
K223856NuEra Tight RF FamilyAugust 11, 2023
K223907NuEra Tight RF Model APMD145.M70-USMay 2, 2023
K210867NuEra Tight RF, NuEra Tight RF PlusApril 21, 2021
K201239NuEra Tight Family, EMS ModelDecember 31, 2020
K200359NuEra Tight, NuEra Tight EMSAugust 11, 2020
K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)December 8, 2016
K153229SuperbiumApril 12, 2016
K151296Family of Radiofrequency System (Biorevital RF MED, ThermiSmooth 250)November 19, 2015
K080374BIOSYAG MEDICAL SYSTEMMay 15, 2008
K072344APL MEDICAL SYSTEMDecember 3, 2007
K043521BIOSYAG 50 MEDMarch 24, 2005
K780510NUCLEAR STETHOSCOPEApril 18, 1978