MDL-1 LASERTRIPTER
Device Facts
| Record ID | K880503 |
|---|---|
| Device Name | MDL-1 LASERTRIPTER |
| Applicant | Candela Laser Corp. |
| Product Code | FFK · Gastroenterology, Urology |
| Decision Date | Jun 17, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4480 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.
Special Controls
The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”
