Cleared Traditional

K240297 - Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) (FDA 510(k) Clearance)

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

K240297 · Us Medical Innovations, LLC · General & Plastic Surgery device
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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

Submission Details

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
22d faster than avg
Panel avg: 114d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.

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All 12
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