K862865 is an FDA 510(k) clearance for the MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE. This device is classified as a Laser, Ent Microsurgical Carbon-dioxide (Class II - Special Controls, product code EWG).
Submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 9, 1987, 164 days after receiving the submission on July 29, 1986.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4500.
| 510(k) Number | K862865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 1986 |
| Decision Date | January 09, 1987 |
| Days to Decision | 164 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | — |
| Product Code | EWG — Laser, Ent Microsurgical Carbon-dioxide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4500 |