The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model 8-b With Os-1 Attachment (c02 Laser For Ent).
| Device ID | K862150 |
| 510k Number | K862150 |
| Device Name: | MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT) |
| 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 For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-09-04 |