Cleared Traditional

K211091 - Deka Tiac II

K211091 is an FDA 510(k) clearance for Deka Tiac II, manufactured by El.En Electronic Engineering Spa. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K211091 · El.En Electronic Engineering Spa · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2021
Decision
186d
Days
Class 2
Risk

K211091 is an FDA 510(k) clearance for the Deka Tiac II. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by El.En Electronic Engineering Spa (Calenzano, IT). The FDA issued a Cleared decision on October 15, 2021 after a review of 186 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 El.En Electronic Engineering Spa devices

FDA 510(k) Submission Details - K211091

510(k) Number K211091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2021
Decision Date October 15, 2021
Days to Decision 186 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
71d slower than avg
Panel avg: 115d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PBX Device Classification - Class 2, Special Controls

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 78
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K211091.
Diacare 7000
K211207 · Globus Sport and Health Technologies, LLC · Jun 2022
Venus BlissMAX
K220592 · Venus Concept USA, Inc. · Apr 2022
Venus BlissMAX
K213308 · Venus Concept USA, Inc. · Jan 2022
Family of Venus RF Systems - Venus Freedom
K211461 · Venus Concept USA, Inc. · Oct 2021
Sectum
K202780 · Neauvia North America · Jul 2021
RF Thermal System
K210129 · Luvo Medical Technologies, Inc. · Jul 2021