Definition: Laser Ablation Of Prostatic Tissue For The Treatment Of Benign Prostatic Hyperplasia
| Device Type ID | 5797 |
| Device Name | Laser, 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 Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| 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) |
| CFR Regulation Number | 878.4810 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OEL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 5797 |
| Device | Laser, Benign Prostatic Hyperplasia |
| Product Code | OEL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology. |
| CFR Regulation Number | 878.4810 [🔎] |