The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model 10-c W/lp-10a/u & Ob-10a/u For Oral/ent Use.
| Device ID | K862865 |
| 510k Number | K862865 |
| Device Name: | MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE |
| Classification | Laser, Ent Microsurgical Carbon-dioxide |
| Applicant | DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Contact | Edward Johansen |
| Correspondent | Edward Johansen DIRECTED ENERGY, INC. 11661 SAN VICENTE BLVD. SUITE 203 Los Angeles, CA 90049 |
| Product Code | EWG |
| CFR Regulation Number | 874.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1987-01-09 |