The following data is part of a premarket notification filed by Directed Energy, Inc. with the FDA for 10-c/sa-10b/u Opt 20-c/20a/u Beam Sa-10b/u Hemorrh.
| Device ID | K871031 |
| 510k Number | K871031 |
| Device Name: | 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH |
| Classification | Laser For Gastro-urology Use |
| 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 | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-16 |
| Decision Date | 1987-05-15 |