FDA product code OEL
Laser, Benign Prostatic Hyperplasia
General, Plastic Surgery·Class 2·21 CFR 878.4810
US regulatory classifications
- US Product Code (FDA)
- OELView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 878.4810View CFR Regulation →
- Medical specialty
- General, Plastic Surgery
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia
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About this record
Laser, Benign Prostatic Hyperplasia 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.