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U.S. Department of Health and Human Services

Product Classification

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Device laser, benign prostatic hyperplasia
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Definition Laser ablation of prostatic tissue for the treatment of benign prostatic hyperplasia.
Physical State The device consists primarily of medical laser and deliver fibers. The fibers are positioned in the prostate or prostatic urethra through endoscopy and direct laser optical energy into the prostate.
Technical Method Laser optical energy is applied to the prostate using endoscopically delivered fibers. Heating of the prostatic tissue leads to necrotic death or direct ablation depending on the temperatures achieved.
Target Area Prostate
Regulation Medical Specialty General & Plastic Surgery
Review Panel General & Plastic Surgery
Product CodeOEL
Premarket Review Office of Device Evaluation (ODE)
Division of Surgical Devices (DSD)
Plastic and Reconstructive Surgery Devices Branch Two - Skin/Wound Dressing/Aesthetic Injectables (PRSB2)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Guidance for Industry and Food and Drug Administration Staff - Guidance for the Non-Clinical and Clinical Investigation of Devices Used for the Treatment of Benign Prostatic Hyperplasia (BPH)
Third Party Review Not Third Party Eligible
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