| 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 Code | OEL |
|---|
| Premarket Review |
Office of Surgical and Infection Control Devices
(OHT4)
General Surgery Devices
(DHT4A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
878.4810
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standards
|
| Guidance Document
|
| Third Party Review |
Not Third Party Eligible |
