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U.S. Department of Health and Human Services

Product Classification

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Device low energy direct current thermal ablation system
Regulation Description Electrosurgical cutting and coagulation device and accessories.
Definition Ablation of soft tissue.
Physical State it includes the LEDC generator, electrodes and accessories
Technical Method it applies a low energy direct current (LEDC) pulse or series of pulses between two electrodes to cause an ablation effect to occur
Target Area soft tissue including cardiac and smooth muscle
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOAB
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
General Surgery Devices Branch One - Light Based/Laser (GSDB1)
Submission Type 510(k)
Regulation Number 878.4400
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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