Cleared Abbreviated

K253480 - Capenergy C Equipments RF C200 and C400...

K253480 is the FDA 510(k) clearance for Capenergy C Equipments RF C200 and C400... by Capenergy Medical S.L.. It is a Class 2 General & Plastic Surgery device (product code PBX) cleared through the Abbreviated 510(k) pathway after a 269-day FDA review.

K253480 · Capenergy Medical S.L. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2026
Decision
269d
Days
Class 2
Risk

K253480 is an FDA 510(k) clearance for the Capenergy C Equipments RF C200 and C400 Drakarian. Classified as Massager, Vacuum, Radio Frequency Induced Heat (product code PBX), Class II - Special Controls.

Submitted by Capenergy Medical S.L. (Sant Joan Despi, ES). The FDA issued a Cleared decision on July 10, 2026 after a review of 269 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Capenergy Medical S.L. devices

Submission Details

510(k) Number K253480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2025
Decision Date July 10, 2026
Days to Decision 269 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
Pathway characteristics
Standards-based clearance path.

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

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