The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for Model 8-b With La-2b Attachment For Ob-gyn Use.
| Device ID | K861845 |
| 510k Number | K861845 |
| Device Name: | MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE |
| Classification | Laser, Surgical, Gynecologic |
| 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 | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-13 |
| Decision Date | 1986-08-11 |