NuEra Tight RF, NuEra Tight RF Plus

Massager, Vacuum, Radio Frequency Induced Heat

BIOS S.r.l.

The following data is part of a premarket notification filed by Bios S.r.l. with the FDA for Nuera Tight Rf, Nuera Tight Rf Plus.

Pre-market Notification Details

Device IDK210867
510k NumberK210867
Device Name:NuEra Tight RF, NuEra Tight RF Plus
ClassificationMassager, Vacuum, Radio Frequency Induced Heat
Applicant BIOS S.r.l. Via Guido Rossa 10/12 Vimodrone,  IT 20090
ContactEliana Russo
CorrespondentEliana Russo
BIOS S.r.l. Via Guido Rossa 10/12 Vimodrone,  IT 20090
Product CodePBX  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-23
Decision Date2021-04-21

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