Cleared Traditional

K231092 - T-SHAPE 2

K231092 is an FDA 510(k) clearance for T-SHAPE 2, manufactured by B&M S.R.L. Marketing Nel Benessere. The device is a Class 2 General & Plastic Surgery device with product code NUV cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K231092 · B&M S.R.L. Marketing Nel Benessere · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2023
Decision
157d
Days
Class 2
Risk

K231092 is an FDA 510(k) clearance for the T-SHAPE 2. Classified as Massager, Vacuum, Light Induced Heating (product code NUV), Class II - Special Controls.

Submitted by B&M S.R.L. Marketing Nel Benessere (Milano, IT). The FDA issued a Cleared decision on September 22, 2023 after a review of 157 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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 B&M S.R.L. Marketing Nel Benessere devices

FDA 510(k) Submission Details - K231092

510(k) Number K231092 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2023
Decision Date September 22, 2023
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUV Device Classification - Class 2, Special Controls

Product Code NUV Massager, Vacuum, Light Induced Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition The Device Is Intended To Temporarily Alter 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 Consultant

Endo Engineering S.R.L.
Chiara Violini

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUV Massager, Vacuum, Light Induced Heating

All 8
Devices cleared under the same product code (NUV) and FDA review panel - the closest regulatory comparables to K231092.
ICOONE Laser Med (also referred to as ICOONE Medical laser)
K211272 · I-Tech Industries Srl · Jun 2021
ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
K182453 · I-Tech Industries Srl · Jan 2019
VELASHAPE
K122579 · Syneron Medical, Ltd. · Sep 2012
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K092195 · Cutera, Inc. · Oct 2009
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD)
K080300 · Cutera, Inc. · Apr 2008
VELASHAPE
K071872 · Syneron Medical, Ltd. · Aug 2007