Cleared Traditional

Aliya® EX System (K253826) - FDA 510(k) Clearance

Also marketed or referenced as:
Aliya® EX Generator Aliya® Needle Aliya® Electrode INUMI™ Flex Needle

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

K253826 · Galvanize Therapeutics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
157d
Days
Class 2
Risk

K253826 is an FDA 510(k) clearance for the Aliya® EX System. Classified as Low Energy Direct Current Thermal Ablation System (product code OAB), Class II - Special Controls.

Submitted by Galvanize Therapeutics, Inc. (Redwood City, US). The FDA issued a Cleared decision on May 7, 2026 after a review of 157 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 Galvanize Therapeutics, Inc. devices

Submission Details

510(k) Number K253826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2025
Decision Date May 07, 2026
Days to Decision 157 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
42d slower than avg
Panel avg: 115d · This submission: 157d
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 Peers - OAB Low Energy Direct Current Thermal Ablation System

All 13
Devices cleared under the same product code (OAB) and FDA review panel - the closest regulatory comparables to K253826.
NanoKnife Generator (H78720300351US0)
K253198 · Angiodynamics · Mar 2026
NanoKnife Generator (H78720300301US0)
K242687 · AngioDynamics, Inc. · Dec 2024
Electroporation System (N3000)
K240376 · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 2024
INUMI™ Flex Needle
K233884 · Galvanize Therapeutics, Inc. · May 2024
Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS)
K240297 · Us Medical Innovations, LLC · May 2024
Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe
K222001 · Zhejiang Curaway Medical Technology Co., Ltd. · Jun 2023