Cleared Traditional

CAPENERGY - C100, C200, C300, C400, C50 (K191202) - FDA 510(k) Clearance

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

K191202 · Capenergy Medical S.L. · General & Plastic Surgery device
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Feb 2020
Decision
281d
Days
Class 2
Risk

K191202 is an FDA 510(k) clearance for the CAPENERGY - C100, C200, C300, C400, C50. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Capenergy Medical S.L. (Sant Joan Despi, Barcelona, ES). The FDA issued a Cleared decision on February 11, 2020 after a review of 281 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 Capenergy Medical S.L. devices

Submission Details

510(k) Number K191202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2019
Decision Date February 11, 2020
Days to Decision 281 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
166d slower than avg
Panel avg: 115d · This submission: 281d
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 K191202.
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
Deka Tiac 1
K183371 · El..En. Electroic Engineering Spa · Dec 2019
EmFace Device
K191855 · Inmode MD , Ltd. · Oct 2019
Venus Bliss
K190743 · Venus Concept USA, Inc. · Jun 2019