K871030 is an FDA 510(k) clearance for the MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.. This device is classified as a Laser For Gastro-urology Use (Class II - Special Controls, product code LNK).
Submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on May 15, 1987, 60 days after receiving the submission on March 16, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K871030 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 16, 1987 |
| Decision Date | May 15, 1987 |
| Days to Decision | 60 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 |