Cleared Traditional

K240297 - Canady Helios Cold Plasma XL-1000CP Abl...

K240297 is an FDA 510(k) clearance for Canady Helios Cold Plasma XL-1000CP Abl..., manufactured by Us Medical Innovations, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAB cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K240297 · Us Medical Innovations, LLC · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
May 2024
Decision
92d
Days
Class 2
Risk

K240297 is an FDA 510(k) clearance for the Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS). Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Us Medical Innovations, LLC (Tacoma Park, US). The FDA issued a Cleared decision on May 3, 2024 after a review of 92 days - within the typical 510(k) review window.

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 Us Medical Innovations, LLC devices

FDA 510(k) Submission Details - K240297

510(k) Number K240297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2024
Decision Date May 03, 2024
Days to Decision 92 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
23d faster than avg
Panel avg: 115d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAB Device Classification - Class 2, Special Controls

Product Code OAB Low Energy Direct Current Thermal Ablation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Ablation Of Soft Tissue
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

Emergo Global Consulting, LLC
Audrey Swearingen

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 - OAB Low Energy Direct Current Thermal Ablation System

All 10
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