Laser, Benign Prostatic Hyperplasia

Product Code: OEL

General & Plastic Surgery Medical Laser Products

Definition: Laser Ablation Of Prostatic Tissue For The Treatment Of Benign Prostatic Hyperplasia.

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as OEL

5797Laser, Benign Prostatic HyperplasiaLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

5797Laser, Benign Prostatic HyperplasiaLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Laser, Benign Prostatic Hyperplasia [30278]21 CFR §878.4810 🔎
Laser, Benign Prostatic Hyperplasia [38651]21 CFR §878.4810 🔎
Laser, Benign Prostatic Hyperplasia [38649]21 CFR §878.4810 🔎
Laser, Benign Prostatic Hyperplasia [38650]21 CFR §878.4810 🔎
Laser, Benign Prostatic Hyperplasia [34006]21 CFR §878.4810 🔎

Maude Adverse Events

AMS-HPS FIBEROPTICS-BPH FIBEROPTIC GREEN LIGHT HPS2009-06-18

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