Cleared Traditional

K161043 - Profound System

K161043 is an FDA 510(k) clearance for Profound System, manufactured by Syneron Candela Corporation. The device is a Class 2 General & Plastic Surgery device with product code PBX cleared through the Traditional 510(k) pathway after a 152-day FDA review.

K161043 · Syneron Candela Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
152d
Days
Class 2
Risk

K161043 is an FDA 510(k) clearance for the Profound System. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Syneron Candela Corporation (Wayland, US). The FDA issued a Cleared decision on September 12, 2016 after a review of 152 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.

FDA 510(k) Submission Details - K161043

510(k) Number K161043 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2016
Decision Date September 12, 2016
Days to Decision 152 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
37d slower than avg
Panel avg: 115d · This submission: 152d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
Janice M. Hogan

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.

Clinical Evidence

ClinicalTrials.gov
NCT02489994 Unknown Interventional Industry-sponsored

Performance of the ePrime System for Cellulite

Clinical Study to Evaluate the Performance of the ePrime System for the Treatment of Cellulite

51
Patients (actual)
4
Sites
Treatment
Purpose
Open label
Masking
Condition studied Cellulite
Study design Single group
Eligibility Female only · 25 Years+ · Healthy volunteers accepted
Principal investigator Macrene Alexiades, MD
Sponsor Syneron Medical (industry)
Started 2014-10-01 → Primary completion 2016-08-01 → Completed 2016-10-01
Primary outcome
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
Secondary outcome
Improvement in cellulite compared to baseline for the upper thighs and buttocks, as assessed by blinded evaluation of clinical photographs
View full study on ClinicalTrials.gov

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

All 79
Devices cleared under the same product code (PBX) and FDA review panel - the closest regulatory comparables to K161043.
truSculpt
K162512 · Cutera, Inc. · Dec 2016
Indiba Diathermia Radiofrequency Device - Activ
K161458 · Indiba USA, Inc. · Oct 2016
TR-100
K161551 · BTL Industries, Inc. · Sep 2016
InMode System MiniFX Handpiece
K160329 · Inmode MD , Ltd. · Aug 2016
EndyMed Contour Handpiece
K161199 · Endymed Medical, Ltd. · Aug 2016
InMode Plus System
K153568 · Inmode MD , Ltd. · Jul 2016