FDA product code OAB
Low Energy Direct Current Thermal Ablation System
General, Plastic Surgery·Class 2·21 CFR 878.4400
US regulatory classifications
- US Product Code (FDA)
- OABView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 878.4400View CFR Regulation →
- Medical specialty
- General, Plastic Surgery
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Eligible
Definition
Ablation of soft tissue
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About this record
Low Energy Direct Current Thermal Ablation System is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.