Cleared Traditional

NuEra Tight, NuEra Tight EMS (K200359) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K200359 · Bios S.R.L. · General & Plastic Surgery device
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Aug 2020
Decision
180d
Days
Class 2
Risk

K200359 is an FDA 510(k) clearance for the NuEra Tight, NuEra Tight EMS. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Bios S.R.L. (Vimodrone, IT). The FDA issued a Cleared decision on August 11, 2020 after a review of 180 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bios S.R.L. devices

Submission Details

510(k) Number K200359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2020
Decision Date August 11, 2020
Days to Decision 180 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 115d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PBX Massager, Vacuum, Radio Frequency Induced Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - PBX Massager, Vacuum, Radio Frequency Induced Heat

All 56
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K200359.
V30 system, V20 system, V10 system, V-VR Hand piece
K202247 · Viora , Ltd. · Dec 2020
Palm NRG cellulite and muscle toning body device
K191940 · Heat IN A Click · Nov 2020
Ultimate Contour, Ultimate Contour Mini
K201475 · CAO Group, Inc. · Oct 2020
V30 System, V20 System, V10 System, V-FR Handpiece
K201064 · Viora , Ltd. · Jul 2020
V30 system, V20 system, V10 system, V-FC Handpiece
K200468 · Viora , Ltd. · May 2020
TempSure System
K200241 · Cynosure, LLC · Mar 2020