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 |