K901723 is an FDA 510(k) clearance for the MDL-2000 LASERTRIPTER. This device is classified as a Laser For Gastro-urology Use (Class II - Special Controls, product code LNK).
Submitted by Candela Laser Corp. (Wayland, US). The FDA issued a Cleared decision on July 13, 1990, 88 days after receiving the submission on April 16, 1990.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K901723 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 16, 1990 |
| Decision Date | July 13, 1990 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | LNK — Laser For Gastro-urology Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4810 |